免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / 64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rectal Cancer | Drug: 64Cu-ATSM | Phase 2 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Multicentric, open prospective study |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer |
| Actual Study Start Date : | April 26, 2019 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | April 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 64Cu ATSM
pretherapeutic 64Cu-ATSM PET/CT scan
|
Drug: 64Cu-ATSM
64 Cu-ATSM PET/CT scan
|
Outcome Measures
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 [ 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 Outcome Measures :
- 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 ]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 [ Time Frame: 4 months ]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 [ Time Frame: 2 years ]Progression Free survival is the delay between surgery and the date of documented disease progression
- 18FDG-PET/CT and 64Cu-PET/CT uptakes [ Time Frame: 45 days ]Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes
- Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images [ Time Frame: 45 days ]Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement
- 64Cu-ATSM toxicity [ Time Frame: 45 days ]64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Mathilde COLOMBIE, MD | +33240679900 ext 9501 | mathilde.colombie@ico.unicancer.fr | |
| Contact: Nadia FLEURY, PhD | +33240679900 ext 9168 | nadia.fleury@ico.unicancer.fr |
Locations
| France | |
| Institut de Cancerologie de l'Ouest (ICO) | Recruiting |
| Angers, France, 49055 | |
| Contact: Mathilde COLOMBIE, MD +33240679900 ext 9501 mathilde.colombie@ico.unicancer.fr | |
| Principal Investigator: Mathilde COLOMBIE, MD | |
| CHU de BREST | Recruiting |
| Brest, France, 29200 | |
| Contact: Pierre Yves SALAUN, MD, PhD +33298223117 pierre-yves.salaun@chu-brest.fr | |
| Principal Investigator: Pierre Yves SALAUN, MD, PhD | |
| Centre Eugene Marquis | Not yet recruiting |
| Rennes, France, 35045 | |
| Contact: Anne DEVILLERS, MD +33299253084 a.devillers@rennes.unicancer.fr | |
| Principal Investigator: Anne DEVILLERS, MD | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76038 | |
| Contact: Pierre VERA, Pr, MD pierre.vera@chb.unicancer.fr | |
| Institut de cancerologie de l'Ouest | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Mathilde COLOMBIE, MD +33240679900 ext 9501 mathilde.colombie@ico.unicancer.fr | |
| Principal Investigator: Mathilde COLOMBIE, MD | |
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Fondation ARC
Investigators
| Principal Investigator: | Mathilde COLOMBIE, MD | Institut de Cancerologie de l'Ouest |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 26, 2019 | ||||||||
| First Posted Date ICMJE | May 15, 2019 | ||||||||
| Last Update Posted Date | May 21, 2021 | ||||||||
| Actual Study Start Date ICMJE | April 26, 2019 | ||||||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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)
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | 64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum) | ||||||||
| Official Title ICMJE | Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Multicentric, open prospective study Masking: None (Open Label)Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Rectal Cancer | ||||||||
| Intervention ICMJE | Drug: 64Cu-ATSM
64 Cu-ATSM PET/CT scan
|
||||||||
| Study Arms ICMJE | Experimental: 64Cu ATSM
pretherapeutic 64Cu-ATSM PET/CT scan
Intervention: Drug: 64Cu-ATSM
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
70 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 2023 | ||||||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03951337 | ||||||||
| Other Study ID Numbers ICMJE | ICO-N-2017-14 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Institut Cancerologie de l'Ouest | ||||||||
| Study Sponsor ICMJE | Institut Cancerologie de l'Ouest | ||||||||
| Collaborators ICMJE | Fondation ARC | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Institut Cancerologie de l'Ouest | ||||||||
| Verification Date | May 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
