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


Condition: Cancer of the Rectum

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01804790

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

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.

View trial on ClinicalTrials.gov