Last updated: March 11, 2024
Sponsor: Institut Cancerologie de l'Ouest
Overall Status: Active - Not Recruiting
Phase
2
Condition
Colorectal Cancer
Digestive System Neoplasms
Rectal Disorders
Treatment
64Cu-ATSM
Clinical Study ID
NCT03951337
ICO-N-2017-14
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed rectum adenocarcinoma
- Locally advanced, non metastatic disease, with or without locoregional lymph nodeinvolvement (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 greaterthan 100 000/mm3
- Creatinine clearance greater than or equal to 50ml/min
- Plan to receive treatment with concurrent chemotherapy and radiation therapy followedby surgery
- Totality of the tumor included in the radiotherapy field
- Written informed consent
- Patient must be affiliated to a Social Health Insurance
Exclusion
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 orin 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 forgeographical, social or psychological reasons
- Agitation; impossibility of lying motionless for at least 1 hour, or knownclaustrophobia
Study Design
Total Participants: 70
Treatment Group(s): 1
Primary Treatment: 64Cu-ATSM
Phase: 2
Study Start date:
April 26, 2019
Estimated Completion Date:
January 31, 2026
Study Description
Connect with a study center
Institut de Cancerologie de l'Ouest (ICO)
Angers, 49055
FranceSite Not Available
CHU de BREST
Brest, 29200
FranceSite Not Available
Centre Eugene Marquis
Rennes, 35045
FranceSite Not Available
Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
Institut de cancerologie de l'Ouest
Saint Herblain, 44805
FranceSite Not Available
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