IRINOTECAN HYDROCHLORIDE TRIHYDRATE for Rectal cancer|Recurrent rectal cancer

Inclusion criteria

• {"criterion_text":"- Signed and dated informed consent\n- Age ≥ 18 years\n- First or second LRRC (histologically proven) ≤ 15 cm from the anal verge\n- Previous pelvic irradiation for the primary rectal cancer or primary recurrence (25-50.4Gy)\n- No distant metastasis\n- 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)\n- Adequate hematologic function : Hemoglobin ≥ 9 g/dL, neutrophil count ≥ 1500/mm3, blood platelets ≥ 100 000/mm3\n- Adequate hepatic function : total bilirubin ≤ 1,5 x ULN, ASAT et ALAT ≤ 3 x ULN, alkalin phosphatases ≤ 3 x ULN\n- Adequate renal function : creatinine clearance ≥ 30 ml/min\n- ECOG performance status < 2\n- 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\n- Patient affiliated to a social security system or beneficiary of the same\n- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures"}

Exclusion criteria

• {"criterion_text":"- Recurrent rectal cancer after local excision\n- Concomitant cancer or medical history of cancer (other than that of rectal disease) within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)\n- 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\n- Symptomatic cardiac or coronary insufficiency\n- Personal or family history of long QT syndrome congenital\n- ECG at screening or baseline (predose) with QT/QTc > 450 msec (male) or QT/QTc > 470 msec (female)\n- Chronic inflammatory bowel disease and/or bowel obstruction, digestive abscess or fistula\n- Patients with hypocalcemia, hypokalemia, hypomagnesemia\n- Progressive active infection (HIV or chronic hepatitis B or C) or any other severe medical condition that may preclude the delivery of treatment\n- Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)\n- If contraindication to FOLFIRINOX, possibility to administred FOLFOX or FOLFIRI +/-EGFR (Contraindication to oxaliplatin: peripheral neuropathy > grade 1 (CTCAE grading system v5.0))\n- Concomitant treatment with millepertuis, yellow fever vaccine, live attenuated vaccine, phenytoin, warfarin or sorivudine (or chemically equivalent)\n- Pregnant or breast-feeding woman\n- Persons deprived of liberty or under guardianship or incapable of giving consent\n- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator"}

Primary endpoints

• {"endpoint_text":"- Proportion of curative surgery (R0 resection)","definition_or_measurement_approach":"Rate measured as the proportion of patients undergoing curative R0 resection (R0 resection rate)."}

Secondary endpoints

• {"endpoint_text":"- 3-year Disease Free and 3-year Overall Survival","definition_or_measurement_approach":"Measured as 3-year disease-free survival and 3-year overall survival."}
• {"endpoint_text":"- Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery","definition_or_measurement_approach":"Assessed using the Dindo classification for surgical morbidity and mortality within 30 days after surgery."}
• {"endpoint_text":"- Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment","definition_or_measurement_approach":"Measured as the proportion of patients receiving the entirety of the allocated neoadjuvant treatment."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Defined as locally recurrent rectal cancer with a ≥50% decrease in size after preoperative treatment; classified as good MRI radiological responders per prior literature criteria."}
• {"endpoint_text":"- Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0","definition_or_measurement_approach":"Treatment-related toxicity graded and reported using NCI CTCAE v5.0; proportions of patients with toxicities will be reported."}
• {"endpoint_text":"- Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 and QLQ-CR29 questionnaires at specified timepoints: baseline, pre-surgery, 6 months, 1 year, and 2 years post-surgery."}

France

Earliest CTIS Part Ii Submission Date

18-06-2024

Latest Decision Or Authorization Date

04-07-2024

Processing Time Days

16

Number Of Sites

22

Number Of Participants

186

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France