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

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

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

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

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.

Connect with a study center

  • Institut de Cancerologie de l'Ouest (ICO)

    Angers, 49055
    France

    Site Not Available

  • CHU de BREST

    Brest, 29200
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35045
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Institut de cancerologie de l'Ouest

    Saint Herblain, 44805
    France

    Site Not Available

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