Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Study Overview
Brief 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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
64Cu ATSM
pretherapeutic 64Cu-ATSM PET/CT scan
Intervention: 64Cu-ATSM (Drug)
Outcomes
Primary Outcomes
Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Time Frame: 4 months
Early tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)
Secondary Outcomes
- 64Cu-ATSM toxicity(45 days)
- Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment(4 months)
- Progression free survival(2 years)
- 18FDG-PET/CT and 64Cu-PET/CT uptakes(45 days)
- Correlation between 64Cu-ATSM uptake and oxidative stress markers(4 months)
- Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images(45 days)