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Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer (Néofirinox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01804790
Recruitment Status : Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE March 1, 2013
First Posted Date  ICMJE March 5, 2013
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
disease-free survival [ Time Frame: 3 years ]
To compare the 3-year disease-free survival between the investigational arm and the control arm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Overall survival [ Time Frame: 7 years ]
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
Official Title  ICMJE Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
Brief Summary National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
Detailed Description Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of the Rectum
Intervention  ICMJE
  • Drug: mFolfirinox
    Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
  • Radiation: Radiotherapy 50 Gy
    5 radiations per week of 2 Gy for 5 weeks
  • Drug: Capecitabine
    1600 mg/m² (800 mg/m² twice daily) for 5 weeks
  • Procedure: TME surgery
  • Drug: mFolfox6 or capecitabine
    oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
Study Arms  ICMJE
  • Active Comparator: Arm A : Radiotherapy + capecitabine
    Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice.
    Interventions:
    • Radiation: Radiotherapy 50 Gy
    • Drug: Capecitabine
    • Procedure: TME surgery
    • Drug: mFolfox6 or capecitabine
  • Experimental: Arm B : Chemotherapy then radiochemotherapy

    Drug: Chemotherapy mFolfirinox

    Investigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks):

    oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles).

    Then followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice.

    Interventions:
    • Drug: mFolfirinox
    • Radiation: Radiotherapy 50 Gy
    • Drug: Capecitabine
    • Procedure: TME surgery
    • Drug: mFolfox6 or capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
461
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
460
Estimated Study Completion Date  ICMJE July 2023
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven rectal adenocarcinoma
  • Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT
  • Resectable tumor, or considered as potentially resectable after CRT
  • No distant metastases
  • Patient eligible for surgery
  • Patient aged from 18 to 75 years
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2.
  • No heart failure or coronary heart disease symptoms (even controlled).
  • No peripheral neuropathy > grade 1
  • No prior radiotherapy of the pelvis for any reason and no previous CT
  • No major comorbidity that may preclude the delivery of treatment and no active infection (HIV or chronic hepatitis B or C).
  • Adequate contraception in fertile patients.
  • Adequate hematologic function
  • Adequate hepatic function
  • Signed written informed consent

Exclusion Criteria:

  • Metastatic disease
  • Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles
  • Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
  • Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
  • Medical history of angina pectoris or myocardial infarction
  • Progressive active infection or any other severe medical condition that could jeopardize treatment administration
  • Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma
  • Patient included in another clinical trial testing an investigational agent.
  • Pregnant or breast-feeding woman.
  • Persons deprived of liberty or under guardianship or incapable of giving consent
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01804790
Other Study ID Numbers  ICMJE PRODIGE 23 - UCGI 23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thierry CONROY, PROF centre Alexis Vautrin les Nancy
PRS Account UNICANCER
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP