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

Institut Cancerologie de l'Ouest

Status and phase

Active, not recruiting

Phase 2

Conditions

Rectal Cancer

Treatments

Drug: 64Cu-ATSM

Study type

Interventional

Funder types

Other

Identifiers

NCT03951337

ICO-N-2017-14

Details and patient eligibility

About

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

Full description

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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