NCT03951337

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

5.2 years

First QC Date

April 26, 2019

Last Update Submit

March 11, 2024

Conditions

Rectal Cancer

Keywords

64Cu-ATSMneoadjuvant treatmentchemoradiotherapysurgeryPositron Emission Tomography (PET)/CT scanPrediction of response to treatmentRodel score

Outcome Measures

Primary Outcomes (1)

  • Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment

    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)

    4 months

Secondary Outcomes (6)

  • Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment

    4 months

  • Correlation between 64Cu-ATSM uptake and oxidative stress markers

    4 months

  • Progression free survival

    2 years

  • 18FDG-PET/CT and 64Cu-PET/CT uptakes

    45 days

  • Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images

    45 days

  • +1 more secondary outcomes

Study Arms (1)

64Cu ATSM

EXPERIMENTAL

pretherapeutic 64Cu-ATSM PET/CT scan

Drug: 64Cu-ATSM

Interventions

64Cu-ATSMDRUG

64 Cu-ATSM PET/CT scan

64Cu ATSM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institut de Cancerologie de l'Ouest (ICO)

Angers, 49055, France

Location

CHU de BREST

Brest, 29200, France

Location

Centre Eugene Marquis

Rennes, 35045, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mathilde COLOMBIE, MD

    Institut de Cancerologie de l'Ouest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Multicentric, open prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 15, 2019

Study Start

April 26, 2019

Primary Completion

July 1, 2024

Study Completion

January 1, 2026

Last Updated

March 12, 2024

Record last verified: 2024-02

Locations

FR(5)