New hope for recurrent rectal cancer: adding radiation before surgery may boost cure rates

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed and dated informed consent * Age ≥18 years * LRRC (histologically proven) ≤ 15 cm from the anal verge * First or second LRRC (histologically proven) ≤ 15 cm from the anal verge * Previous pelvic irradiation for the primary rectal cancer or primary recurrence (25-50.4Gy) * 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 ≥ 1500/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 : creatinine clearance ≥ 30 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 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 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 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 * Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL) * If contraindication to FOLFIRINOX, possibility to administred FOLFOX or FOLFIRI +/-EGFR (Contraindication to oxaliplatin: peripheral neuropathy \> grade 1 (CTCAE grading system v5.0) * 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