Recurrent rectal cancer after local excision
Conditions
Interventions
Trade Name: XELODA
Product Name: CAPECITABINE
Pharmaceutical Form: Tablet
Trade Name: ELOXATINE
Product Name: OXALIPLATINE
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: CAMP
Sponsors
CHU DE BORDEAUX
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.;Secondary Objective: To compare neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on: - 3-year Disease Free Survival and 3-year Overall Survival; - Surgical morbidity and mortality (Dindo classification) at 30 days; - Compliance to the neoadjuvant treatment; - Good tumor response; - Quality of life at two years after surgery; - To assess the toxicity of neoadjuvant treatment ;Primary end point(s): Proportion of curative surgery (R0 resection);Timepoint(s) of evaluation of this end point: After Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- 3-year Disease Free and 3-year Overall Survival 2- Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery 3- Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment 4- Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature) 5- Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery 6- Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0;Timepoint(s) of evaluation of this end point: 1- From surgery until 3 years of follow 2- From surgery until 30 days after surgery 3- From beginning of neoadjuvant treatment until surgery 4- Arm A : at 6 weeks after neoadjuvant treatment ; Arm B : at 4 weeks after neoadjuvant treatment 5- Before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery 6- From beginning of neoadjuvant treatment until surgery | — |
Countries
France
Contacts
Public ContactPROJECT MANAGER
CHU DE BORDEAUX
Outcome results
None listed