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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 : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of the Rectum Drug: mFolfirinox Radiation: Radiotherapy 50 Gy Drug: Capecitabine Procedure: TME surgery Drug: mFolfox6 or capecitabine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2012
Actual Primary Completion Date : September 2019
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 years ]
    To compare the 3-year disease-free survival between the investigational arm and the control arm.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804790


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Thierry CONROY, PROF centre Alexis Vautrin les Nancy
More Information
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Additional Information:

Publications of Results:

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01804790    
Other Study ID Numbers: PRODIGE 23 - UCGI 23
2011-004406-25 ( EudraCT Number )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
rectum
cancer
locally advanced
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents