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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
64Cu-ATSM
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring 64Cu-ATSM, neoadjuvant treatment, chemoradiotherapy, surgery, Positron Emission Tomography (PET)/CT scan, Prediction of response to treatment, Rodel score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de Cancerologie de l'Ouest (ICO)Recruiting
  • CHU de BRESTRecruiting
  • Centre Eugene Marquis
  • Centre Henri BecquerelRecruiting
  • Institut de cancerologie de l'OuestRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

64Cu ATSM

Arm Description

pretherapeutic 64Cu-ATSM PET/CT scan

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Late 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)
Correlation between 64Cu-ATSM uptake and oxidative stress markers
Aggressive zones corresponding to high redox potential areas will be assessed by Immuno-histochemical analysis on the surgical sample and on the pre-therapeutic biopsy
Progression free survival
Progression Free survival is the delay between surgery and the date of documented disease progression
18FDG-PET/CT and 64Cu-PET/CT uptakes
Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes
Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images
Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement
64Cu-ATSM toxicity
64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection

Full Information

First Posted
April 26, 2019
Last Updated
August 29, 2022
Sponsor
Institut Cancerologie de l'Ouest
Collaborators
Fondation ARC
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1. Study Identification

Unique Protocol Identification Number
NCT03951337
Brief Title
64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
Official Title
Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
Collaborators
Fondation ARC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
64Cu-ATSM, neoadjuvant treatment, chemoradiotherapy, surgery, Positron Emission Tomography (PET)/CT scan, Prediction of response to treatment, Rodel score

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Multicentric, open prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
64Cu ATSM
Arm Type
Experimental
Arm Description
pretherapeutic 64Cu-ATSM PET/CT scan
Intervention Type
Drug
Intervention Name(s)
64Cu-ATSM
Intervention Description
64 Cu-ATSM PET/CT scan
Primary Outcome Measure Information:
Title
Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Description
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)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Description
Late 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)
Time Frame
4 months
Title
Correlation between 64Cu-ATSM uptake and oxidative stress markers
Description
Aggressive zones corresponding to high redox potential areas will be assessed by Immuno-histochemical analysis on the surgical sample and on the pre-therapeutic biopsy
Time Frame
4 months
Title
Progression free survival
Description
Progression Free survival is the delay between surgery and the date of documented disease progression
Time Frame
2 years
Title
18FDG-PET/CT and 64Cu-PET/CT uptakes
Description
Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes
Time Frame
45 days
Title
Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images
Description
Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement
Time Frame
45 days
Title
64Cu-ATSM toxicity
Description
64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde COLOMBIE, MD
Phone
+33240679900
Ext
9501
Email
mathilde.colombie@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia ALLAM, PhD
Phone
+33240679826
Email
nadia.allam@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde COLOMBIE, MD
Organizational Affiliation
Institut de Cancerologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest (ICO)
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde COLOMBIE, MD
Phone
+33240679900
Ext
9501
Email
mathilde.colombie@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Mathilde COLOMBIE, MD
Facility Name
CHU de BREST
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Yves SALAUN, MD, PhD
Phone
+33298223117
Email
pierre-yves.salaun@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Pierre Yves SALAUN, MD, PhD
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35045
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DEVILLERS, MD
Phone
+33299253084
Email
a.devillers@rennes.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Anne DEVILLERS, MD
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre VERA, Pr, MD
Email
pierre.vera@chb.unicancer.fr
Facility Name
Institut de cancerologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde COLOMBIE, MD
Phone
+33240679900
Ext
9501
Email
mathilde.colombie@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Mathilde COLOMBIE, MD

12. IPD Sharing Statement

Learn more about this trial

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

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