Evaluation of the 64Cu-ATSM PET-CT as a predictor of the response to neo-adjuvant treatment in locally advanced rectal cancers
Phase 1
- Conditions
- men and / or women older than 18, newly diagnosed for locally advanced rectal cancerMedDRA version: 20.0Level: PTClassification code 10038019Term: Rectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-002079-17-FR
- Lead Sponsor
- INSTITUT DE CANCEROLOGIE DE L'OUEST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the intensity of the tumor uptake of 64Cu-ATSM as a predictor of the histological response (estimated by a Rödel score of 3 or 4) to neo-adjuvant therapy by radiochemotherapy according to the CAP 50 regimen in 25 fractions of 2 Gy, in patients with locally advanced rectal cancer;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method