64cu-atsm pet/ct in rectum cancer (tep 64cu-atsm-rectum)

Conditions: Rectal Cancer

Summary: this phase ii trial is assessing how 64cu-atsm (64cu-copper(ii) diacetylbis(n4-methylthiosemicarbazone)) pet/ct scan could predict neo adjuvant treatment response in rectum cancer locally advanced

the purpose of this study is to evaluate early and late tumor uptake of 64cu-atsm in predicting histological response to neo-adjuvant chemo-radiotherapy treatment in patients with locally advanced rectal cancer. patients receive pre-therapeutic ct scan, pelvic mri and 18fdg (fluorodeoxyglucose) pet/ct (positron emission tomography) scan within 45 days before enrollment. 64cu-atsm pet/ct scan is done before chemoradiotherapy treatment start. about 3 mbq/kg of 64cu-atsm are injected intravenously, two acquisition sequences are performed 1 hour and 23 to 25 hours after injection in order to evaluate early and late tumor uptake of 64cu-atsm. patients are treated for 5 weeks by capecitabine chemotherapy (1600 mg/m2/day) combined to 50 gy radiotherapy. pelvic mri is performed 4 weeks after chemotherapy in order to evaluate the treatment efficacy. surgery is scheduled 6 to 8 weeks after chemoradiotherapy. tissue samples from previously collected rectal biopsy (obtained for diagnosis) and from surgery are used for assessing oxidative stress markers by immuno-histochemical analysis. chest, abdomen and pelvis ct scan is performed every 6 months after surgery in order to assess progression free survival.

Eligibility criteria:
inclusion criteria: * histologically confirmed rectum adenocarcinoma * locally advanced, non metastatic disease, with or without locoregional lymph node involvement (greater than or equal to t3 +/- n), first-line therapy * 18 years and older * performance status equal to 0 or 1 * fertile patients must use effective contraception * hemoglobin greater than 9g/dl, neutrophils greater than 1 500/mm3, platelets greater than 100 000/mm3 * creatinine clearance greater than or equal to 50ml/min * plan to receive treatment with concurrent chemotherapy and radiation therapy followed by surgery * totality of the tumor included in the radiotherapy field * written informed consent * patient must be affiliated to a social health insurance exclusion criteria: * metastatic disease * patient contraindicated for capecitabine or 5fu (5-fluoro-uracile) derivatives (history of severe and unexpected reactions to fluoropyrimidine-containing therapy, known hypersensitivity to 5fu, to any of the excipients, or known total dpd (dihydropyrimidine déshydrogénase) deficiency) * known contraindication to perform mri * previous treatment with pelvic radiotherapy * chronic inflammatory bowel disease, malabsorption, lack of colonic integrity * diarrhea grade greater than 2 * contraindication to surgery * bilateral total hip prosthesis * other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix) * pregnant or nursing patient * individual deprived of liberty or placed under the authority of a tutor * impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons * agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia

Keywords: 64cu-atsm neoadjuvant treatment chemoradiotherapy surgery positron emission tomography (pet)/ct scan prediction of response to treatment rodel score