<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/NCT03808337</url>
  </required_header>
  <id_info>
    <org_study_id>18-486</org_study_id>
    <nct_id>NCT03808337</nct_id>
  </id_info>
  <brief_title>Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease</brief_title>
  <official_title>PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered&#xD;
      to all sites of disease in participants with 1-5 metastases will increase the length of time&#xD;
      before participants' disease gets worse.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>To compare overall survival (OS) between standard of care and SBRT arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Metastatic Non-Small Cell Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Standare of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiotherapy (SBRT) + Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiotherapy/SBRT</intervention_name>
    <description>Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.</description>
    <arm_group_label>Stereotactic Body Radiotherapy (SBRT) + Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Systemic Therapy/Standard of Care</intervention_name>
    <description>Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.</description>
    <arm_group_label>Standare of Care</arm_group_label>
    <arm_group_label>Stereotactic Body Radiotherapy (SBRT) + Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic disease detected on imaging and histologically confirmed&#xD;
&#xD;
               -  Triple negative breast cancer (TNBC) (ER &lt;1%, PR &lt;1%, her-2-neu 0-1+ by IHC or&#xD;
                  FISH-negative or as determined by MD discretion),&#xD;
&#xD;
               -  ER+ breast cancer receiving chemotherapy regardless of HER2 status&#xD;
&#xD;
               -  Non-small cell lung cancer (NSCLC) without known targetable molecular alterations&#xD;
                  in EGFR, ALK, or ROS1&#xD;
&#xD;
               -  NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history&#xD;
                  of disease progression on first-line tyrosine kinase inhibitor&#xD;
&#xD;
          -  Patient can either have newly diagnosed metastatic disease, or have non-progressive&#xD;
             disease on systemic therapy (for at least 3 months on systemic imaging)&#xD;
&#xD;
          -  Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5&#xD;
             or fewer discrete disease sites that are technically amendable to SBRT (with the&#xD;
             exception that if the primary disease is not amendable to SBRT it is allowed to be&#xD;
             treated with conventionally fractionated or hypfractionated radiotherapy).&#xD;
&#xD;
               -  Two lesions in such close proximity to one another that treatment with one&#xD;
                  isocenter is more accurate and safer in the liver, lungs, or other similar&#xD;
                  anatomic locations should be viewed as one site of metastatic disease treatment&#xD;
&#xD;
               -  Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal&#xD;
                  extension) can represent one site of disease in the spine; non-contiguous lesions&#xD;
                  in vertebral bodies separated by one vertebral body free of disease should be&#xD;
                  viewed as 2 sites of treatment&#xD;
&#xD;
               -  If the clinical scenario deem that other forms of local therapy may be more&#xD;
                  suitable for the metastatic disease, such as surgical resection and&#xD;
                  interventional radiology-guided ablation, patients would be able to undergo other&#xD;
                  forms of local therapy with discussion with the PI.&#xD;
&#xD;
          -  For de novo stage IV patients (patients with metastatic disease at first&#xD;
             presentation), primary disease must be treatable with local therapy. If the primary&#xD;
             tumor or other locoregional disease has not been definitively treated and is not&#xD;
             amendable to SBRT, it must be treated with conventionally fractionated or&#xD;
             hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10.&#xD;
             If the clinical scenario deem that other forms of local therapy may be more suitable&#xD;
             for the primary and locoregional disease, such as surgical resection and&#xD;
             interventional radiology-guided ablation, patients would be able to undergo other&#xD;
             forms of local therapy with discussion with the PI.&#xD;
&#xD;
          -  If primary disease was previously treated with local therapy in the form of surgery or&#xD;
             radiation, any new local/regional disease recurrence should be technically treatable&#xD;
             with SBRT or hypofractionated radiation. If the clinical scenario deem that other&#xD;
             forms of local therapy may be more suitable for the local/regional recurrent disease,&#xD;
             such as surgical resection and interventional radiology-guided ablation, patients&#xD;
             would be able to undergo other forms of local therapy with discussion with the PI.&#xD;
&#xD;
          -  Patients may receive palliative radiotherapy for symptomatic metastases or primary&#xD;
             disease prior to enrollment provided that there is at least one other non-irradiated&#xD;
             lesion amenable to SBRT at the time of enrollment.&#xD;
&#xD;
          -  Patients with brain metastases are eligible if these lesions have been treated prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  ECOG Performance status 0 - 2.&#xD;
&#xD;
          -  Age &gt;/= 18 years.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Female subjects must either be of non-reproductive potential (i.e. post-menopausal by&#xD;
             history: &gt;/= 60 years old or no menses for 1&gt; year without an alternative medical&#xD;
             cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history&#xD;
             of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks&#xD;
             prior to starting treatment.&#xD;
&#xD;
          -  Adequate baseline organ function to allow SBRT to all relevant targets, as determined&#xD;
             by the treating radiation oncologist based on lesion location, lesion size, and&#xD;
             proximity to relevant organs at risk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious medical co-morbidities precluding radiotherapy, determined at the discretion&#xD;
             of the treating investigator.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Other active malignancy within the last year, even if without evidence of disease.&#xD;
&#xD;
          -  Clinical or radiological evidence of spinal cord compression&#xD;
&#xD;
          -  Malignant pleural effusion or ascites.&#xD;
&#xD;
          -  Patients whose entry to the trial will cause unacceptable clinical delays in their&#xD;
             planned management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Xu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Xu, MD, PhD</last_name>
    <phone>646-888-6863</phone>
    <email>xua@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wanqing Zhi, MD, PhD</last_name>
    <phone>631-623-4246</phone>
    <email>zhiw@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hartford Healthcare</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles Rutter, MD</last_name>
      <phone>860-972-2803</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>WCHN Norwalk Hospital - Data Collection</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Gilbo, MD</last_name>
      <phone>203-221-0059</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baptist Alliance - McI</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupesh Kotecha, MD</last_name>
      <phone>786-596-2000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center @ Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Xu, MD, PhD</last_name>
      <phone>646-888-6863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alyson McIntosh, MD</last_name>
      <phone>610-402-0700</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jonatha Yang, MD, PhD</last_name>
      <phone>206-598-4100</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stereotactic body radiotherapy</keyword>
  <keyword>SBRT</keyword>
  <keyword>18-486</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT03808337
org study id: 18-486
nct id: NCT03808337
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered
      to all sites of disease in participants with 1-5 metastases will increase the length of time
      before participants' disease gets worse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: Up to 2 years
description: To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.
measure: Overall Survival
time frame: Up to 2 years
description: To compare overall survival (OS) between standard of care and SBRT arms.
arm group label: Standare of Care
arm group type: Active Comparator
description: Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.
arm group label: Stereotactic Body Radiotherapy (SBRT) + Standard of Care
arm group type: Experimental
description: Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.
intervention type: Radiation
intervention name: Stereotactic Body Radiotherapy/SBRT
description: Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.
arm group label: Stereotactic Body Radiotherapy (SBRT) + Standard of Care
intervention type: Drug
intervention name: Systemic Therapy/Standard of Care
description: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.
arm group label: Standare of Care
arm group label: Stereotactic Body Radiotherapy (SBRT) + Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Xu, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Amy Xu, MD, PhD
phone: 646-888-6863
email: xua@mskcc.org
last name: Wanqing Zhi, MD, PhD
phone: 631-623-4246
email: zhiw@mskcc.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Triple Negative Breast Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)