Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 14, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating locally advanced rectal cancer. It compares two treatment strategies: one group of patients will receive preoperative chemotherapy alone (using a specific combination of drugs called modified FOLFIRINOX), while the other group will receive chemotherapy followed by chemoradiotherapy (a combination of chemotherapy and radiation). The main goal is to see if the chemotherapy-only approach can be just as effective in preventing cancer progression over three years.

To participate in the trial, patients must be 18 years or older and have a specific type of rectal cancer that meets certain criteria based on imaging tests. For example, the cancer must be located within 10 cm of the anal opening, and there should be enough healthy tissue around the tumor. The trial is currently looking for 540 participants across 42 centers in France. Those who join can expect to receive close monitoring and support throughout the study. It’s also important for participants to use effective birth control during the treatment period and for six months afterward if they are capable of becoming pregnant. This study aims to explore if avoiding pelvic radiation is a safe and effective option for patients with rectal cancer before surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)
• • cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound),
• • Pretreatment predictive circumferential margin \> 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
• • Patients must be 18 years old or older
• • A World Health Organization (WHO/ECOG) performance status of 0 or 1
• • Informed consent signed
• • Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• Exclusion Criteria:
• • Rectal tumor \> 10 cm from the anal verge on MRI (sagittal slide)
• • cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter
• • Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
• • Metastatic disease
• • Prior pelvic irradiation or any contraindication to pelvic irradiation
• • Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy
• • Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion.
• • Recent or concomitant treatment with brivudine is contraindicated
• • contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection
• • contraindication to irinotecan : inflammatory bowel disease, bilirubin serum level \> 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status \> 2,
• • Concomitant treatment with millepertuis.
• * contraindication to oxaliplatin :
• • \*bone marrow insufficiency before treatment initiation (neutrophil count \<2x109/L and/or platelet count \<100x109/L), peripheral neuropathy with permanent invalidity before treatment initiation
• • severe renal insufficiency (Creatinin clearance \<30 ml/min)
• • contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency
• • contraindications to capecitabin : severe renal insufficiency (Creatinin clearance \<30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase
• • live attenuated vaccine should not be used during and 6 months after preoperative treatment.
• • Previous colorectal cancer
• • Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years
• • Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• • protected adults
• • Pregnancy or breastfeeding
• • Patient with no national health or universal plan affiliation coverage.