- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259363
Oxaliplatin in Rectal Cancer
Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
- Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
- Phase II: To determine the treatment efficacy according to response rates from phase I.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Barcelona, Spain
- Sanofi-Aventis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main criteria are listed hereafter:
Inclusion Criteria:
- ECOG: 0-2
- Histological proved rectal adenocarcinoma
- No chemotherapy treatment on the previous 6 months before inclusion.
- No previous pelvic radiotherapy treatment
Exclusion Criteria:
- Important Biological abnormality (renal, hepatic and/or hematological)
- Intestinal occlusion or subocclusion
- Peripheral neuropathy
- Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
- Participation in other trials on the previous 4 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase I : Maximum Tolerated Dose & Recommended Dose
Time Frame: Days 1, 15, 29
|
Days 1, 15, 29
|
Phase II : Response and resectability rate.
Time Frame: 6 cycles in 6 months
|
6 cycles in 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: JOSÉ Mª TABOADA, Sanofi
Study record dates
Study Major Dates
Study Start
Primary 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
Other Study ID Numbers
- L_8330
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 Neoplasms
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Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage 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
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
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SafeHeal IncTerminatedSafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study (SAFE-2)Colorectal Cancer | Rectal Cancer | Rectal Tumor | Rectal/AnalUnited States, France, Belgium
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National Cancer Institute (NCI)TerminatedStage III Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage II Rectal Cancer AJCC v8 | Locally Advanced Rectal CarcinomaUnited States
-
City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
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National Cancer Institute (NCI)NRG OncologyCompletedRectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage II Rectal Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)CompletedRectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage II Rectal Cancer AJCC v7United States
-
Peking University Third HospitalRecruitingRectal Cancer Stage II | Rectal Cancer Stage IIIChina
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Prof. Dr. med. Claus RödelJohann Wolfgang Goethe University Hospital; Deutsche Krebshilfe e.V., Bonn...CompletedRectal Neoplasms | Rectal Cancer Stage II | Rectal Cancer Stage IIIGermany
Clinical Trials on Oxaliplatin
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Xijing HospitalUnknownGastrointestinal CancerChina
-
Lin ChenUnknownGastric AdenocarcinomaChina
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Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Chonnam National University... and other collaboratorsCompletedColorectal CancerKorea, Republic of
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical CancerUnited States, Canada
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States
-
St. Jude Children's Research HospitalNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol SpecificUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisNational Cancer Institute, FranceSuspended
-
Jenny DrottCompletedColorectal NeoplasmsSweden
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SanofiCompleted