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Clinical Trials/NCT03951337
NCT03951337Active, not recruitingPhase 2

Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer

Institut Cancerologie de l'Ouest5 sites in 1 country70 target enrollmentStarted: April 26, 2019Last updated:
Conditions
Interventions
Drugs

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

Experimental

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)

Investigators

Sponsor
Institut Cancerologie de l'Ouest
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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