<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028766</url>
  </required_header>
  <id_info>
    <org_study_id>RG_15-139</org_study_id>
    <secondary_id>2015-003583-37</secondary_id>
    <secondary_id>ISRCTN76291951</secondary_id>
    <nct_id>NCT03028766</nct_id>
  </id_info>
  <brief_title>WEE1 Inhibitor With Cisplatin and Radiotherapy: A Trial in Head and Neck Cancer</brief_title>
  <acronym>WISTERIA</acronym>
  <official_title>A Phase I Trial of WEE1 Inhibition With Chemotherapy and Radiotherapy as Adjuvant Treatment, and a Window of Opportunity Trial With Cisplatin in Patients With Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Research UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is to determine what dose of a drug called AZD1775 can safely be given in&#xD;
      combination with cisplatin before surgery and with chemo-radiotherapy after surgery in&#xD;
      patients with Head and Neck Cancer. The Investigators will also get some preliminary&#xD;
      information regarding the effectiveness of this combined treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with head and neck cancer with high-risk features are at increased risk of relapse&#xD;
      after surgery. Surgery, often followed by cisplatin chemotherapy and radiotherapy is&#xD;
      currently the standard treatment offered. Whilst chemo-radiotherapy improves cure rates,&#xD;
      outcomes remain poor, and treatment has a significant impact on quality of life. Chemotherapy&#xD;
      has yet to find a definitive role prior to surgery. There is therefore an urgent need to&#xD;
      develop more effective treatments which improve cure rates for this patient population.&#xD;
&#xD;
      The purpose of this trial is to see whether incorporating a drug called AZD1775 into the&#xD;
      management of head and neck cancer offers the possibility of addressing these clinical&#xD;
      issues. AZD1775 is a drug that has been shown to increase the effect of cisplatin and of&#xD;
      radiotherapy when tested in the laboratory. The blood samples and tumour biopsies taken&#xD;
      during the trial will be important in learning as much as possible about the effects of&#xD;
      AZD1775 on the body and to investigate how the tumour might develop resistance to the drug.&#xD;
&#xD;
      The WISTERIA trial is for patients aged between 18 and 70 years with cancer of the oral&#xD;
      cavity, larynx and hypopharynx who are to undergo surgery. Patients recruited to Group A must&#xD;
      have accessible tumours for re-biopsy, whilst patients recruited to Group B will be at high&#xD;
      risk of relapse after surgery.&#xD;
&#xD;
      The primary objective of this trial is to see what dose of AZD1775 can safely be given in&#xD;
      combination with cisplatin before surgery (Group A) and with chemo-radiotherapy after surgery&#xD;
      (Group B). The Investigators will also get some preliminary information regarding the&#xD;
      effectiveness of this combined treatment. To find the safe and effective dose of AZD1775,&#xD;
      different doses will be tested for each Group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2017</start_date>
  <completion_date type="Actual">February 3, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recommended dose(s) of AZD1775</measure>
    <time_frame>Group A - Up to 42 days from start of treatment; Group B - Up to 12 weeks from the start of treatment</time_frame>
    <description>Group A: The highest safe dose of AZD1775 in combination with cisplatin with a predefined target Dose Limiting Toxicity probability of 25% for up to 42 days from start of treatment.&#xD;
Group B: The maximum tolerated dose of AZD1775 in combination with cisplatin/radiotherapy with a target DLT of 30% for up to 12 weeks from the start of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety profile of AZD1775 for Group A and Group B by reporting of all Adverse Events, Serious Adverse Events, Suspected Unexpected Adverse Reactions, deaths, deviations and withdrawal as assessed by the Safety Committee.</measure>
    <time_frame>From registration, while on treatment and during follow up periods</time_frame>
    <description>Safety profile of AZD1775 in combination with cisplatin in Group A and cisplatin/radiotherapy in Group B.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival in Groups A and B</measure>
    <time_frame>Patients will be followed-up clinically for 12 weeks in Group A and for 12 months in Group B.</time_frame>
    <description>Disease-free survival is defined as the time from trial entry to date of disease recurrence, progression or patient death until end of follow up period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hypopharynx Squamous Cell Carcinoma</condition>
  <condition>Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Larynx Cancer</condition>
  <arm_group>
    <arm_group_label>Group A - Pre-operative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the cohort specified dose of AZD1775 by mouth, twice a day for 3 days, commencing on days 1 and 8. Cisplatin 40mg/m2 IV delivered over 1 hour on day 8. Patients in this group will commence surgery within 42 days of commencing pre-operative chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Post-operative:</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will received the cohort specified dose of AZD1775 by mouth, twice a day for 3 days on days 2, 9, 23 and 30. Cisplatin 40mg/m2 IV delivered over 1 hour on days 2, 9, 16, 23 and 30. Intensity Modulated Radiotherapy will be delivered 5 days a week (once daily, Monday to Friday) for 6 weeks commencing within 3 months of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD1775</intervention_name>
    <description>AZD1775 is a potent, selective small molecule inhibitor of WEE1</description>
    <arm_group_label>Group A - Pre-operative</arm_group_label>
    <arm_group_label>Group B - Post-operative:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Chemotherapy drug</description>
    <arm_group_label>Group A - Pre-operative</arm_group_label>
    <arm_group_label>Group B - Post-operative:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Intensity Modulated Radiotherapy</description>
    <arm_group_label>Group B - Post-operative:</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of oral, laryngeal or hypopharyngeal squamous cell&#xD;
             carcinoma&#xD;
&#xD;
          -  Multi-Disciplinary Team (MDT) recommendation for surgical resection with curative&#xD;
             intent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0/1&#xD;
&#xD;
          -  Age ≥18 to ≤70 years&#xD;
&#xD;
          -  Creatinine clearance, measured by Glomerular Filtration Rate (GFR), ≥ 60 ml/min at&#xD;
             baseline calculated using local practice calculation. If this is ≤ 60 ml/min then an&#xD;
             isotopic GFR may be carried out and must be &gt; 60 ml/min&#xD;
&#xD;
          -  Acceptable cardiac function. If significant cardiac history, then required for patient&#xD;
             to have Left Ventricular Ejection Fraction (LVEF) ≥55% by echocardiogram (ECHO) or&#xD;
             Multiple Gated Acquisition Scan (MUGA, if ECHO is equivocal)&#xD;
&#xD;
          -  Normal liver and bone marrow function:&#xD;
&#xD;
               -  Haemoglobin (Hb) ≥10.0 g/dL or ≥100 g/L&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1.5 x 109/L&#xD;
&#xD;
               -  Absolute platelet count ≥100 x 109/L&#xD;
&#xD;
               -  Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≤2.5 upper limit&#xD;
                  of normal (ULN)&#xD;
&#xD;
               -  Total bilirubin ≤1.5 ULN (except for patients with known Gilbert's syndrome)&#xD;
&#xD;
          -  Male and female participants must agree to take appropriate measures to prevent&#xD;
             pregnancy. Contraceptive measures should be used for 2 weeks prior to trial entry,&#xD;
             during the trial and for at least 6 months after last receiving treatment. Acceptable&#xD;
             methods of contraception include total abstinence (if this is the patient's usual and&#xD;
             preferred lifestyle choice), tubal ligation, combined oral, transdermal or&#xD;
             intra-vaginal hormonal contraceptives, medroxyprogesterone injections (e.g.&#xD;
             Depo-Provera), copper-banded intra-uterine devices; hormone impregnated intra-uterine&#xD;
             systems and vasectomised partners. All methods of contraception (with the exception of&#xD;
             total abstinence) should be used in combination with the use of a condom by their male&#xD;
             sexual partner for intercourse.&#xD;
&#xD;
        Inclusion criteria Group A - in addition to general criteria&#xD;
&#xD;
          -  Accessible tumours for re-biopsy under local anaesthetic or via ultrasound guided&#xD;
             biopsy&#xD;
&#xD;
        Inclusion criteria Group B - in addition to general criteria&#xD;
&#xD;
          -  High-risk histopathological features after surgical resection, i.e. nodal&#xD;
             extra-capsular spread and/or tissue resection margin &lt;1 mm as agreed at MDT&#xD;
&#xD;
          -  Patients who have previously registered to Group A can be considered for inclusion in&#xD;
             Group B&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous treatment for the same cancer, or previous head and neck malignancy,&#xD;
             apart from laser excision of carcinoma in situ, with minimal residual functional&#xD;
             deficit or registration and treatment in Group A prior to surgery&#xD;
&#xD;
          -  Patients with cancer of the oropharynx or non-primary cancer will not be included&#xD;
&#xD;
          -  Any metastatic disease from any primary site&#xD;
&#xD;
          -  Use of an Investigational Medicinal Product (IMP) concurrently or within 4 weeks of&#xD;
             starting this trial&#xD;
&#xD;
          -  Uncontrolled intercurrent illness, which will interfere with the patient's&#xD;
             participation in the trial, e.g.:&#xD;
&#xD;
               -  myocardial infarction within 6 months&#xD;
&#xD;
               -  congestive cardiac failure&#xD;
&#xD;
               -  unstable angina&#xD;
&#xD;
               -  symptomatic cardiomyopathy&#xD;
&#xD;
               -  chronic infections&#xD;
&#xD;
               -  active peptic ulcer or liver disease&#xD;
&#xD;
               -  serious psychiatric condition limiting ability to comply with trial protocol&#xD;
&#xD;
          -  Clinical evidence of current heart failure (≥New York Heart Association (NYHA) Class&#xD;
             II)&#xD;
&#xD;
          -  Clinical evidence of atrial fibrillation (with heart rate &gt;100 bpm, within 6 months&#xD;
             prior to trial entry)&#xD;
&#xD;
          -  Unstable ischaemic heart disease (Myocardial Infarction within 6 months prior to trial&#xD;
             entry or angina requiring the use of nitrates greater than once weekly)&#xD;
&#xD;
          -  Patients who have a history of Torsades de pointes (unless all risk factors that&#xD;
             contributed to Torsades de pointes have been corrected)&#xD;
&#xD;
          -  Active gastro-intestinal disease that might limit absorption of study drug, e.g.&#xD;
             coeliac disease, Crohn's disease, ulcerative colitis, pancreatic insufficiency&#xD;
&#xD;
          -  Evidence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering protocol compliance&#xD;
&#xD;
          -  Participation in another interventional clinical trial whilst taking part in this&#xD;
             trial&#xD;
&#xD;
          -  Patients who are unable to discontinue any prohibited drug and unable to tolerate a&#xD;
             washout period for at least 14 days prior to trial entry&#xD;
&#xD;
          -  Clinical judgement by the Investigator that the patient should not participate in the&#xD;
             study&#xD;
&#xD;
          -  Known hypersensitivity to the study drugs or active substances or excipients of the&#xD;
             preparations&#xD;
&#xD;
          -  Pregnant or breast feeding patients&#xD;
&#xD;
          -  Significant pre-existing neuropathy which currently interferes with the patient's&#xD;
             daily life&#xD;
&#xD;
          -  Mean resting corrected QTc interval using the Fridericia formula (QTcF) &gt;450 msec&#xD;
             (male) and &gt;470 msec (female) (as calculated per institutional standards) obtained&#xD;
             from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long&#xD;
             QT syndrome&#xD;
&#xD;
          -  Inability to swallow oral medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hisham Mehanna</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Birmingham Nhs Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James' University Hospital, Leeds Teaching Hospital NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals</name>
      <address>
        <city>London</city>
        <zip>W1T 7HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clatterbridge Cancer Centre</name>
      <address>
        <city>Wirral</city>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.birmingham.ac.uk/research/crctu/trials/wisteria/index.aspx</url>
    <description>Trial Website</description>
  </link>
  <link>
    <url>https://www.isrctn.com/ISRCTN76291951</url>
    <description>ISRCTN (including basic results)</description>
  </link>
  <reference>
    <citation>Kong A, Good J, Kirkham A, Savage J, Mant R, Llewellyn L, Parish J, Spruce R, Forster M, Schipani S, Harrington K, Sacco J, Murray P, Middleton G, Yap C, Mehanna H. Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: the WISTERIA trial protocol. BMJ Open. 2020 Mar 16;10(3):e033009. doi: 10.1136/bmjopen-2019-033009.</citation>
    <PMID>32184305</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Laryngeal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adavosertib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The CRCTU is committed to responsible and controlled sharing of anonymised clinical trial data with the wider research community to maximise potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the MRC Methodology Hubs, will be available for sharing with researchers outside of the trials team within 6 months of the primary publication. More detailed information on the CRCTU's Data Sharing Policy and the mechanism for obtaining data can be found on the CRCTU website: https://www.birmingham.ac.uk/research/activity/mds/trials/crctu/index.aspx.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of the primary publication.</ipd_time_frame>
    <ipd_access_criteria>See Plan Description above.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028766
org study id: RG_15-139
secondary id: 2015-003583-37
secondary id: ISRCTN76291951
nct id: NCT03028766
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial is to determine what dose of a drug called AZD1775 can safely be given in
      combination with cisplatin before surgery and with chemo-radiotherapy after surgery in
      patients with Head and Neck Cancer. The Investigators will also get some preliminary
      information regarding the effectiveness of this combined treatment.
Patients with head and neck cancer with high-risk features are at increased risk of relapse
      after surgery. Surgery, often followed by cisplatin chemotherapy and radiotherapy is
      currently the standard treatment offered. Whilst chemo-radiotherapy improves cure rates,
      outcomes remain poor, and treatment has a significant impact on quality of life. Chemotherapy
      has yet to find a definitive role prior to surgery. There is therefore an urgent need to
      develop more effective treatments which improve cure rates for this patient population.

      The purpose of this trial is to see whether incorporating a drug called AZD1775 into the
      management of head and neck cancer offers the possibility of addressing these clinical
      issues. AZD1775 is a drug that has been shown to increase the effect of cisplatin and of
      radiotherapy when tested in the laboratory. The blood samples and tumour biopsies taken
      during the trial will be important in learning as much as possible about the effects of
      AZD1775 on the body and to investigate how the tumour might develop resistance to the drug.

      The WISTERIA trial is for patients aged between 18 and 70 years with cancer of the oral
      cavity, larynx and hypopharynx who are to undergo surgery. Patients recruited to Group A must
      have accessible tumours for re-biopsy, whilst patients recruited to Group B will be at high
      risk of relapse after surgery.

      The primary objective of this trial is to see what dose of AZD1775 can safely be given in
      combination with cisplatin before surgery (Group A) and with chemo-radiotherapy after surgery
      (Group B). The Investigators will also get some preliminary information regarding the
      effectiveness of this combined treatment. To find the safe and effective dose of AZD1775,
      different doses will be tested for each Group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recommended dose(s) of AZD1775
time frame: Group A - Up to 42 days from start of treatment; Group B - Up to 12 weeks from the start of treatment
description: Group A: The highest safe dose of AZD1775 in combination with cisplatin with a predefined target Dose Limiting Toxicity probability of 25% for up to 42 days from start of treatment.
Group B: The maximum tolerated dose of AZD1775 in combination with cisplatin/radiotherapy with a target DLT of 30% for up to 12 weeks from the start of treatment.
measure: Safety profile of AZD1775 for Group A and Group B by reporting of all Adverse Events, Serious Adverse Events, Suspected Unexpected Adverse Reactions, deaths, deviations and withdrawal as assessed by the Safety Committee.
time frame: From registration, while on treatment and during follow up periods
description: Safety profile of AZD1775 in combination with cisplatin in Group A and cisplatin/radiotherapy in Group B.
measure: Disease-free survival in Groups A and B
time frame: Patients will be followed-up clinically for 12 weeks in Group A and for 12 months in Group B.
description: Disease-free survival is defined as the time from trial entry to date of disease recurrence, progression or patient death until end of follow up period.
arm group label: Group A - Pre-operative
arm group type: Experimental
description: Patients will receive the cohort specified dose of AZD1775 by mouth, twice a day for 3 days, commencing on days 1 and 8. Cisplatin 40mg/m2 IV delivered over 1 hour on day 8. Patients in this group will commence surgery within 42 days of commencing pre-operative chemotherapy.
arm group label: Group B - Post-operative:
arm group type: Experimental
description: Patients will received the cohort specified dose of AZD1775 by mouth, twice a day for 3 days on days 2, 9, 23 and 30. Cisplatin 40mg/m2 IV delivered over 1 hour on days 2, 9, 16, 23 and 30. Intensity Modulated Radiotherapy will be delivered 5 days a week (once daily, Monday to Friday) for 6 weeks commencing within 3 months of surgery.
intervention type: Drug
intervention name: AZD1775
description: AZD1775 is a potent, selective small molecule inhibitor of WEE1
arm group label: Group A - Pre-operative
arm group label: Group B - Post-operative:
intervention type: Drug
intervention name: Cisplatin
description: Chemotherapy drug
arm group label: Group A - Pre-operative
arm group label: Group B - Post-operative:
intervention type: Radiation
intervention name: Radiotherapy
description: Intensity Modulated Radiotherapy
arm group label: Group B - Post-operative:
other name: IMRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hisham Mehanna
role: Principal Investigator
affiliation: University of Birmingham
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
url: https://www.birmingham.ac.uk/research/crctu/trials/wisteria/index.aspx
description: Trial Website
url: https://www.isrctn.com/ISRCTN76291951
description: ISRCTN (including basic results)
citation: Kong A, Good J, Kirkham A, Savage J, Mant R, Llewellyn L, Parish J, Spruce R, Forster M, Schipani S, Harrington K, Sacco J, Murray P, Middleton G, Yap C, Mehanna H. Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: the WISTERIA trial protocol. BMJ Open. 2020 Mar 16;10(3):e033009. doi: 10.1136/bmjopen-2019-033009.
PMID: 32184305
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Head and Neck Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Laryngeal Neoplasms
mesh term: Adavosertib
sharing ipd: Yes
ipd description: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The CRCTU is committed to responsible and controlled sharing of anonymised clinical trial data with the wider research community to maximise potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the MRC Methodology Hubs, will be available for sharing with researchers outside of the trials team within 6 months of the primary publication. More detailed information on the CRCTU's Data Sharing Policy and the mechanism for obtaining data can be found on the CRCTU website: https://www.birmingham.ac.uk/research/activity/mds/trials/crctu/index.aspx.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of the primary publication.
ipd access criteria: See Plan Description above.