- 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

Intervention:

  • Drug: mFolfirinox
  • Radiation: Radiotherapy 50Gy
  • Drug: Capecitabine
  • Procedure: TME surgery
  • Drug: mFolfox6 or capecitabine

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01804790

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: disease-free survival
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: 7 years
  • Safety Issue:

Estimated Enrollment: 460

Study Start Date: January 2012

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histogically 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
  • WHO/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.

Contact:

  • Trevor Stanbury
  • 33144235567

Locations:

  • Centre hospitalier Universitaire d'Amiens
  • Amiens France
  • ICO - Site Paul Papin
  • Angers France
  • Centre hospitalier d'Auxerre
  • Auxerre France
  • Centre Hospitalier de Beauvais
  • Beauvais France
  • Institut de Cancérologie de Franche Comté
  • Besancon France
  • Centre Hospitalier de Blois
  • Blois France
  • Hopital Avicenne
  • Bobigny France
  • Clinique Tivoli
  • Bordeaux France
  • Hopital Saint Andre
  • Bordeaux France
  • Institut Bergonie
  • Bordeaux France
  • Centre Francois Baclesse
  • Caen France
  • Chd de La Roche Sur Yon - Les Oudairies
  • La Roche-sur-yon France
  • Centre Bourgogne
  • Lille France
  • Centre Oscar Lambret
  • Lille France
  • Centre Léon Bérard
  • Lyon France
  • Hopital Prive Jean Mermoz
  • Lyon France
  • Ap Hm - Hopital de La Timone - Adultes
  • Marseille France
  • Institut de Cancérologie de Franche Comté
  • Montbeliard France
  • Centre Azuréen de cancérologie
  • Mougins France
  • Hopital Emile Muller
  • Mulhouse France
  • centre Alexis Vautrin
  • Nancy France
  • Polyclinique de Gentilly
  • Nancy France
  • Centre Antoine Lacassagne
  • Nice France
  • Groupe Hospitalier La Pitie-Salpetriere
  • Paris France
  • Institut Mutualiste Montsouris
  • Paris France
  • Hopital Haut Leveque
  • Pessac France
  • Centre Hospitalier Regional D'Annecy
  • Pringy France
  • Hopital Robert Debre
  • Reims France
  • Institut Jean Godinot
  • Reims France
  • Clinique Armoricaine de Radiologie
  • Saint-brieuc France
  • Hopital Saint Gregoire
  • Saint-gregoire France
  • Clinique Mutualiste de L'Estuaire
  • Saint-nazaire France
  • Centre Hospitalier de la Réunion - Site du GHSR
  • Saint-pierre France
  • ICO - Site René Gauducheau
  • St Herblain France
  • Centre Paul Strauss
  • Strasbourg France
  • Gustave Roussy
  • Villejuif France

View trial on ClinicalTrials.gov