- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619696
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.
Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Toulouse, France, 31059
- CHU Toulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.
Exclusion Criteria:
- synchonous metastatis
- previous malignant tumour
- previous radiotherapy/ chemotherapy
- performance status WHO>2
- contraindication to 5 FU
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acceptation rate of the entire sequence by eligible patients
Time Frame: 13 weeks
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acceptation rate of the entire sequence by eligible patients
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
radiological changes while on chimiotherapy, to tumour regression, and prognosis
Time Frame: 13 weeks
|
radiological changes while on chimiotherapy, to tumour regression, and prognosis
|
13 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillaume Portier, PhD, CHU Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenocarcinoma
- Rectal Neoplasms
Other Study ID Numbers
- 0932103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Adenocarcinoma
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Memorial Sloan Kettering Cancer CenterRecruitingRectal Cancer | Rectal Adenocarcinoma | Adenocarcinoma of the Rectum | Locally Advanced Rectal Adenocarcinoma | HER2 Positive Rectal AdenocarcinomaUnited States
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Rectal Adenocarcinoma | Recurrent Rectal CancerUnited States
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National Cancer Institute (NCI)CompletedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Adenocarcinoma of the RectumUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Rectal Carcinoma | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Rectal Mucinous Adenocarcinoma | Rectal Signet Ring Cell Adenocarcinoma | Stage IIA Rectal Cancer AJCC v7 | Stage IIB Rectal Cancer AJCC v7 | Stage IIC Rectal Cancer...United States
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National Cancer Institute (NCI)RecruitingMetastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IV Colon Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Unresectable Colon Adenocarcinoma | Unresectable Rectal AdenocarcinomaUnited States, Puerto Rico
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M.D. Anderson Cancer CenterActive, not recruitingMetastatic Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC... and other conditionsUnited States
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Fox Chase Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)Active, not recruitingMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal CancerUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IV Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Locally...United States
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National Cancer Institute (NCI)CompletedRecurrent Rectal Carcinoma | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Rectal Mucinous Adenocarcinoma | Rectal Signet Ring Cell Adenocarcinoma | Stage IIA Rectal Cancer... and other conditionsUnited States
Clinical Trials on Pelvic MRI and F MISO TEP
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Centre Henri BecquerelUnknownSquamous Cell Carcinoma of the OropharynxFrance
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University of OxfordCompletedHypoxia in Rectal CancerUnited Kingdom
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University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceWithdrawn
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University Hospital, LimogesRecruiting
-
Institut Cancerologie de l'OuestPoitiers University Hospital; IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg... and other collaboratorsCompletedProstate AdenocarcinomaFrance
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)Active, not recruitingAdvanced Prostate CancerUnited States
-
Assistance Publique Hopitaux De MarseilleUnknown
-
University of MichiganAssociation of University Radiologists; GE Radiology Research Academic FellowshipCompletedAdenomyosis | Uterine Fibroids | Uterine BleedingUnited States
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Central Hospital, Nancy, FranceCompleted
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University Health Network, TorontoCompletedHyperparathyroidism, Primary | Positron-Emission Tomography | 18F-fluorocholineCanada