A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for locally recurrent rectal cancer (GRECCAR – PRODIGE – FRENCH)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 186

Inclusion Criteria

- Signed and dated informed consent
- Age =18 years
- LRRC (histologically proven) = 15 cm from the anal verge
- Previous pelvic irradiation for the primary rectal cancer
- No distant metastasis
- Resectable locally recurrent rectal cancer (according to the International consensus, absolute contraindications for resectabililty are bilateral sciatic nerve involvement, circumferential bone involvement, high sacral involvement requiring total sacrectomy; relative contraindications for resectabilty are sciatic notch involvement and encasement external iliac vessels)
- Adequate hematologic function : Hemoglobin = 9 g/dL, leukocytes = 4000/mm3, neutrophil count = 2000/mm3, blood platelets = 100 000/mm3
- Adequate hepatic function : total bilirubin = 1,5 x ULN, ASAT et ALAT = 3 x ULN, alkalin phosphatases = 3 x ULN
- Adequate renal function : plasmatic creatinine = 1,25 x ULN or creatinine clearance = 60 ml/min
- ECOG performance status < 2
- Women not sterilized by the first treatment (ovarian transposition) and males (and their female partners) patients agree to use two methods of effective contraception (one of them being a barrier method) during the study, for at least 6 months for men and 4 months for women after the last administration of study treatment.
- Patient affiliated to a social security system or beneficiary of the same
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Recurrent rectal cancer after local excision
- Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
- Contraindication for chemotherapy (refer to Summary of characteristics of the products of the study drugs available at http://base-donnees-publique.medicaments.gouv.fr) or radiotherapy or surgery
- Symptomatic cardiac or coronary insufficiency
- Personal or family history of long QT syndrome congenital.
- ECG at screening or baseline (predose) with QT/QTc > 450 msec (male) or QT/QTc > 470 msec (female)
- Chronic inflammatory bowel disease and/or bowel obstruction
- Patients with hypocalcemia, hypokalemia, hypomagnesemia
- Progressive active infection (HIV or chronic hepatitis B or C) or any other severe medical condition that may preclude the delivery of treatment
- Dihydropyrimidine deshydrogenase (DPD) deficiency
- Peripheral neuropathy > grade 1 (CTCAE grading system v5.0)
- Concomitant treatment with millepertuis, yellow fever vaccine, live attenuated vaccine, phenytoin, warfarin or sorivudine (or chemically equivalent)
- 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, as assessed by investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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