<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/NCT03000374</url>
  </required_header>
  <id_info>
    <org_study_id>GEMCAD-1601</org_study_id>
    <secondary_id>2016-002333-29</secondary_id>
    <nct_id>NCT03000374</nct_id>
  </id_info>
  <brief_title>Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery</brief_title>
  <acronym>PIER</acronym>
  <official_title>Preoperative Induction Therapy With 12 Weeks of Panitumumab in Combination With mFOLFOX-6 in an Enriched Population (Quadruple Wild-Type) of Patients With mrT3 Rectal Cancer of the Middle Third With Clear Mesorectal Fascia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol Multidisciplinario del Cancer Digestivo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pivotal S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Espanol Multidisciplinario del Cancer Digestivo</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance&#xD;
      imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for&#xD;
      preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of&#xD;
      panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response&#xD;
      (pCR)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase II, nonrandomized single-arm trial of preoperative treatment with mFOLFOX-6 and&#xD;
      panitumumab in an enriched population of patients with rectal adenocarcinoma of intermediate&#xD;
      risk, screened by MRI, without mutations in KRAS, BRAF, NRAS and PI3K. All patients enrolled&#xD;
      in the study will receive 12 weeks of the investigational product (mFOLFOX-6 with&#xD;
      panitumumab) every 14 days for six cycles, unless unacceptable toxicity occurs or progression&#xD;
      is detected. After this treatment, response will be evaluated by diffusion-weighted MRI and&#xD;
      endoscopy. In the absence of disease progression, patients eligible for R0 resection will&#xD;
      undergo total mesorectal excision (TME). After surgery, patients will receive mFOLFOX6 x 6&#xD;
      cycles. In the case of intolerance to FOLFOX-panitumumab, disease progression or&#xD;
      ineligibility for R0 resection, patients will receive chemoradiotherapy with capecitabine 825&#xD;
      mg/m2 every 12 hours concomitantly with radiotherapy (RT) with a total dose of 50.4 Gy. At&#xD;
      the end of this treatment, patients will undergo TME between 6-8 weeks after finishing the&#xD;
      CRT. If a patient has received 4 or more neoadjuvant cycles of FOLFOX-panitumumab before&#xD;
      unacceptable toxicity or progression, it will be considered that the neoadjuvant treatment&#xD;
      has been completed and the patient will have no additional neoadjuvant treatment but surgery.&#xD;
      If the patient has received &lt;4 cycles of neoadjuvant treatment, neoadjuvant CRT will be&#xD;
      administered.&#xD;
&#xD;
      If a patient has an acceptable toxicity or disease progression or a R0 surgery is not&#xD;
      possible to be performed and the patient received CRT, the patient will be followed up for 24&#xD;
      months, from the enrollment of the last patient in the trial, or until progression occurs, in&#xD;
      order to assess progression-free survival and all the data regarding surgery and CRT will be&#xD;
      recorded in the eCRF. If a patient withdraws consent and refuses to continue participating in&#xD;
      the study, follow-up evaluations must be discontinued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2017</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathologic complete response (pCR)</measure>
    <time_frame>Up to 16-18 weeks after first treatment administration</time_frame>
    <description>Pathologic CR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of R0 resection and free mesorectal fascia (or circumferential margin)</measure>
    <time_frame>Up to 16-18 weeks after first treatment administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor regression grade (TRG)</measure>
    <time_frame>Up to 16-18 weeks after first treatment administration</time_frame>
    <description>the residual tumor after preoperative treatment is evaluated semi-quantitatively using the 5-point regression grading scale established by Dworak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of tumor downstaging (mrT versus ypT)</measure>
    <time_frame>Up to 16-18 weeks after first treatment administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of surgery</measure>
    <time_frame>Up to 16-18 weeks after first treatment administration</time_frame>
    <description>According to the histopathology report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events and changes in laboratory results</measure>
    <time_frame>All AEs that occur up until 30 days after the last dose of investigational product will be recorded. Serious and nonserious AEs related with the study treatment that appear up until 30 days after the administration of the last dose should be reported.</time_frame>
    <description>The adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA), version 18.1 or later, and evaluated using the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>Over 30 days after surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of local recurrence</measure>
    <time_frame>At 3 years after recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis rate</measure>
    <time_frame>At 3 years after recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>At 3 years after recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>At 3 years after recruitment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Panitumumab + mFOLFOX-6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- Modified FOLFOX-6 regimen: 5-Fluorouracil (5-FU), oxaliplatin and leucovorin will be administered intravenously once every 14 days, according to the mFOLFOX-6 regimen:&#xD;
Day 1: Oxaliplatin 85 mg/m² in IV infusion of 250-500 mL and leucovorin 200 mg/m² IV, both injected over two hours, followed by 5-FU 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².&#xD;
- Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.&#xD;
Treatment will continue until 6 cycles have been administered, followed by surgery, 5 weeks +/- 1 week after the last dose of neoadjuvant treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Panitumumab</intervention_name>
    <description>Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.</description>
    <arm_group_label>Panitumumab + mFOLFOX-6</arm_group_label>
    <other_name>Vectibix 20 mg/ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5Fluorouracil</intervention_name>
    <description>Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².</description>
    <arm_group_label>Panitumumab + mFOLFOX-6</arm_group_label>
    <other_name>5-FU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Once every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU</description>
    <arm_group_label>Panitumumab + mFOLFOX-6</arm_group_label>
    <other_name>Any marketed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leucovorin</intervention_name>
    <description>Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU</description>
    <arm_group_label>Panitumumab + mFOLFOX-6</arm_group_label>
    <other_name>Any marketed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent form, and willingness and ability to comply with the&#xD;
             requirements of the protocol;&#xD;
&#xD;
          2. Men or women with rectal cancer, age ≥ 18 and &lt;75 years;&#xD;
&#xD;
          3. Histologically documented adenocarcinoma of the rectum. All other histologic types are&#xD;
             excluded. A biopsy of the rectal primary tumor must be available (between 1-4), with&#xD;
             tumor representation &gt; 50% in each sample. The samples will be sent to Val d'Hebron&#xD;
             Institute of Oncology (VHIO) for molecular determination. The blocks of the biopsies&#xD;
             will be sent included in paraffin.&#xD;
&#xD;
          4. Rectal cancer candidate for R0 resection with preservation of the rectal sphincter.&#xD;
&#xD;
          5. Tumors with the following characteristics on high-resolution thin-slice (3 mm) MRI:&#xD;
&#xD;
               1. mrT3&#xD;
&#xD;
               2. Tumors of the middle third, defined as tumors whose distal edge is ≤ 12 cm of the&#xD;
                  anal verge or below the peritoneal reflection and above ≥ 2 cm of the anorectal&#xD;
                  junction.&#xD;
&#xD;
               3. Absence of MRF invasion, defined as a distance ≥ 1 mm between the tumor and the&#xD;
                  fascia;&#xD;
&#xD;
          6. Absence of mutations in KRAS (mutations in KRAS exon 2 [codons 12/13], exon 3 [codons&#xD;
             59/61] and exon 4 [codon 117/146], NRAS (NRAS exon 2 [codons 12/13], exon 3 [codons&#xD;
             59/61] and exon 4 [codons 117/146]), BRAF (exon 15 [codon 600] and PI3KCA in exons 9&#xD;
             and 20&#xD;
&#xD;
          7. ECOG performance status ≤ 2;&#xD;
&#xD;
          8. Hematological status:&#xD;
&#xD;
               -  Neutrophils (ANC) ≥ 1.5 x 109/L;&#xD;
&#xD;
               -  Platelets ≥ 100 x 109/L;&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL;&#xD;
&#xD;
          9. Adequate renal function: serum creatinine &lt;1.5 x upper limit of normal (ULN);&#xD;
&#xD;
         10. Adequate liver function:&#xD;
&#xD;
               -  Serum bilirubin ≤ 1.5 x ULN,&#xD;
&#xD;
               -  Alkaline phosphatase &lt; 5 x ULN,&#xD;
&#xD;
               -  AST/ALT &lt; 3 x ULN;&#xD;
&#xD;
         11. Regular monitoring feasible;&#xD;
&#xD;
         12. In women of childbearing potential, a negative serum pregnancy test within 1 week (7&#xD;
             days) before the start of study treatment;&#xD;
&#xD;
         13. Women must commit to using reliable and appropriate methods of contraception for up to&#xD;
             at least six months after the end of the study treatment (when applicable). Men with a&#xD;
             partner of childbearing potential must agree to use a method of contraception and&#xD;
             their partners must use another contraceptive method for the duration of the trial.&#xD;
             Sexual abstinence will be accepted as a contraception method, with the duration and&#xD;
             considerations stablished by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mucinous adenocarcinoma.&#xD;
&#xD;
          2. N2 lymph node involvement, defined as: 4 or more lymph nodes in the mesorectum showing&#xD;
             morphological signs of metastatic involvement on MRI. A lymph node is considered&#xD;
             malignant when:&#xD;
&#xD;
               1. Short axis &gt; 9 mm.&#xD;
&#xD;
               2. Short axis 5-9 mm and ≥2 of the following criteria:&#xD;
&#xD;
                  i Rounded appearance. ii Heterogeneous margin. iii Heterogeneous signal&#xD;
                  intensity.&#xD;
&#xD;
               3. Short axis &lt; 5 mm AND round shape AND heterogeneous margin AND heterogeneous&#xD;
                  signal intensity.&#xD;
&#xD;
          3. Extramesorectal lymph node involvement: an involved extramesorectal lymph node is&#xD;
             defined as a lymph node in the obturator area with a short axis &gt; 8 mm, round shape&#xD;
             and heterogeneous signal..&#xD;
&#xD;
          4. Prior treatment with panitumumab or cetuximab;&#xD;
&#xD;
          5. Preexisting permanent neuropathy (grade ≥ 2 NCI-CTCAE);&#xD;
&#xD;
          6. Concomitant antitumor treatment not foreseen in the protocol (e.g., chemotherapy,&#xD;
             targeted molecular therapy, immunotherapy);&#xD;
&#xD;
          7. Treatment with any other investigational medicinal product within the 28 days prior to&#xD;
             study entry;&#xD;
&#xD;
          8. Other simultaneous or prior malignancy, except: i) properly treated uterine cervix&#xD;
             carcinoma in situ, ii) basal or squamous cell skin carcinoma, iii) cancer in complete&#xD;
             remission for a period &gt; 5 years;&#xD;
&#xD;
          9. Evidence of metastatic disease in additional studies or in the physical examination;&#xD;
&#xD;
         10. Any other severe and uncontrolled nonmalignant disease, major surgery or traumatic&#xD;
             injury in the last 28 days;&#xD;
&#xD;
         11. Pregnant or breastfeeding women;&#xD;
&#xD;
         12. Patients with known allergy to any excipient of the investigational products;&#xD;
&#xD;
         13. Clinically significant cardiovascular disease, including myocardial infarction,&#xD;
             unstable angina, symptomatic congestive heart failure or cardiac arrhythmia in the&#xD;
             year before randomization in the study.&#xD;
&#xD;
         14. Intestinal occlusion: In the case of intestinal occlusion, patients may be enrolled in&#xD;
             the study after performing a derivative stoma.&#xD;
&#xD;
         15. Interstitial Lung Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Fernández-Martos, MD</last_name>
    <role>Study Director</role>
    <affiliation>Initia Centro Oncológico Integral</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>3203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sabadell</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Joan Despí Moisés Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Panitumumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03000374
org study id: GEMCAD-1601
secondary id: 2016-002333-29
nct id: NCT03000374
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance
      imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for
      preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of
      panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response
      (pCR)
Phase II, nonrandomized single-arm trial of preoperative treatment with mFOLFOX-6 and
      panitumumab in an enriched population of patients with rectal adenocarcinoma of intermediate
      risk, screened by MRI, without mutations in KRAS, BRAF, NRAS and PI3K. All patients enrolled
      in the study will receive 12 weeks of the investigational product (mFOLFOX-6 with
      panitumumab) every 14 days for six cycles, unless unacceptable toxicity occurs or progression
      is detected. After this treatment, response will be evaluated by diffusion-weighted MRI and
      endoscopy. In the absence of disease progression, patients eligible for R0 resection will
      undergo total mesorectal excision (TME). After surgery, patients will receive mFOLFOX6 x 6
      cycles. In the case of intolerance to FOLFOX-panitumumab, disease progression or
      ineligibility for R0 resection, patients will receive chemoradiotherapy with capecitabine 825
      mg/m2 every 12 hours concomitantly with radiotherapy (RT) with a total dose of 50.4 Gy. At
      the end of this treatment, patients will undergo TME between 6-8 weeks after finishing the
      CRT. If a patient has received 4 or more neoadjuvant cycles of FOLFOX-panitumumab before
      unacceptable toxicity or progression, it will be considered that the neoadjuvant treatment
      has been completed and the patient will have no additional neoadjuvant treatment but surgery.
      If the patient has received <4 cycles of neoadjuvant treatment, neoadjuvant CRT will be
      administered.

      If a patient has an acceptable toxicity or disease progression or a R0 surgery is not
      possible to be performed and the patient received CRT, the patient will be followed up for 24
      months, from the enrollment of the last patient in the trial, or until progression occurs, in
      order to assess progression-free survival and all the data regarding surgery and CRT will be
      recorded in the eCRF. If a patient withdraws consent and refuses to continue participating in
      the study, follow-up evaluations must be discontinued.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic complete response (pCR)
time frame: Up to 16-18 weeks after first treatment administration
description: Pathologic CR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0).
measure: Rates of R0 resection and free mesorectal fascia (or circumferential margin)
time frame: Up to 16-18 weeks after first treatment administration
measure: Tumor regression grade (TRG)
time frame: Up to 16-18 weeks after first treatment administration
description: the residual tumor after preoperative treatment is evaluated semi-quantitatively using the 5-point regression grading scale established by Dworak
measure: Rate of tumor downstaging (mrT versus ypT)
time frame: Up to 16-18 weeks after first treatment administration
measure: Quality of surgery
time frame: Up to 16-18 weeks after first treatment administration
description: According to the histopathology report
measure: Adverse events and changes in laboratory results
time frame: All AEs that occur up until 30 days after the last dose of investigational product will be recorded. Serious and nonserious AEs related with the study treatment that appear up until 30 days after the administration of the last dose should be reported.
description: The adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA), version 18.1 or later, and evaluated using the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
measure: Surgical complications
time frame: Over 30 days after surgery.
measure: Rate of local recurrence
time frame: At 3 years after recruitment
measure: Distant metastasis rate
time frame: At 3 years after recruitment
measure: Disease free survival
time frame: At 3 years after recruitment
measure: Overall survival
time frame: At 3 years after recruitment
arm group label: Panitumumab + mFOLFOX-6
arm group type: Experimental
description: - Modified FOLFOX-6 regimen: 5-Fluorouracil (5-FU), oxaliplatin and leucovorin will be administered intravenously once every 14 days, according to the mFOLFOX-6 regimen:
Day 1: Oxaliplatin 85 mg/m² in IV infusion of 250-500 mL and leucovorin 200 mg/m² IV, both injected over two hours, followed by 5-FU 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².
- Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.
Treatment will continue until 6 cycles have been administered, followed by surgery, 5 weeks +/- 1 week after the last dose of neoadjuvant treatment
intervention type: Drug
intervention name: Panitumumab
description: Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.
arm group label: Panitumumab + mFOLFOX-6
other name: Vectibix 20 mg/ml
intervention type: Drug
intervention name: 5Fluorouracil
description: Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².
arm group label: Panitumumab + mFOLFOX-6
other name: 5-FU
intervention type: Drug
intervention name: Oxaliplatin
description: Once every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU
arm group label: Panitumumab + mFOLFOX-6
other name: Any marketed
intervention type: Drug
intervention name: Leucovorin
description: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
arm group label: Panitumumab + mFOLFOX-6
other name: Any marketed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Carlos Fernández-Martos, MD
role: Study Director
affiliation: Initia Centro Oncológico Integral
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country: Spain
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Leucovorin
mesh term: Fluorouracil
mesh term: Oxaliplatin
mesh term: Panitumumab
sharing ipd: No