Rectal CancerPhase 2NCT03951337
64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
A Phase 2 study testing 64Cu-ATSM in people with Rectal Cancer, run by Institut Cancerologie de l'Ouest at 5 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- 64Cu-ATSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Apr 2019to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Institut de Cancerologie de l'Ouest (ICO)
Angers, 49055
CHU de BREST
Brest, 29200
Centre Eugene Marquis
Rennes, 35045
Centre Henri Becquerel
Rouen, 76038
Institut de cancerologie de l'Ouest
Saint-Herblain, 44805
About this study
Official title: Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
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
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- 64Cu-ATSM
- Keywords
- 64Cu-ATSM, neoadjuvant treatment, chemoradiotherapy, surgery, Positron Emission Tomography (PET)/CT scan, Prediction of response to treatment, Rodel score
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-ATSMDrug
64 Cu-ATSM PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| 64Cu ATSM | Experimental | pretherapeutic 64Cu-ATSM PET/CT scan Receives: Drug: 64Cu-ATSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 4 months
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
Measured: 4 months
Progression free survival
Progression Free survival is the delay between surgery and the date of documented disease progression
Measured: 2 years
18FDG-PET/CT and 64Cu-PET/CT uptakes
Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes
Measured: 45 days
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
Measured: 45 days
64Cu-ATSM toxicity
64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start26 Apr 2019
- Primary completionJul 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentric, open prospective study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARC
- Responsible party
- Sponsor
- Investigators
- Mathilde COLOMBIE, MD, Principal investigator, Institut de Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951337
- Sponsor's protocol ID
- ICO-N-2017-14
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
- ClinicalTrials.gov ID
- NCT03951337
- Acronym / sponsor ID
- ICO-N-2017-14
- Conditions
- Rectal Cancer
- Keywords
- 64Cu-ATSM, neoadjuvant treatment, chemoradiotherapy, surgery, Positron Emission Tomography (PET)/CT scan, Prediction of response to treatment, Rodel score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Fondation ARC
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentric, open prospective study
| Arm | Type | Receives |
|---|---|---|
| 64Cu ATSM | Experimental | Drug: 64Cu-ATSMpretherapeutic 64Cu-ATSM PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-ATSM64 Cu-ATSM PET/CT scan | Drug | 64Cu ATSM |
Primary outcome
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)
6 secondary outcomes
Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Time frame: 4 months
Correlation between 64Cu-ATSM uptake and oxidative stress markers
Time frame: 4 months
Progression free survival
Time frame: 2 years
18FDG-PET/CT and 64Cu-PET/CT uptakes
Time frame: 45 days
Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images
Time frame: 45 days
64Cu-ATSM toxicity
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde COLOMBIE, MD principal investigator
Institut de Cancerologie de l'Ouest
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 64Cu-ATSM in people with Rectal Cancer, run by Institut Cancerologie de l'Ouest at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.