64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Cancerologie de l'Ouest
• Collaborator: Fondation ARC

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