- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016639
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer (CORGI)
Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.
CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant.
CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Karlstad, Sweden
- Centralsjukhuset, Dept of Oncology
-
Lund, Sweden
- University Hospital Lund
-
Malmö, Sweden
- University Hospital Malmö, Dept of Oncology
-
Stockholm, Sweden
- Karolinska University Hospital
-
Uppsala, Sweden
- Akademiska Sjukhuset
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 18 years of age
- Measurable disease according to RECIST
- ECOG Performance Status 0-1
- ANC over 1.5 x 10 9/L
- Platelets over 100 x 10 9/L
- Creatinine less than 1.5 x ULN
- Bilirubin less than 1.5 x ULN
- ALT less than 2.5 x ULN
- Signed informed concent
Exclusion Criteria:
- Prior radiotherapy to the same local
- Prior chemotherapy for locally advanced or metastatic disease
- Pregnancy or breast feeding
- Peripheral neuropathy more than grade 1
- Uncontrolled diarrhéa
- Other serious uncontrolled concomitant illness
- Lymph node metastasis that can not be included in the GTV (gross tumor volume), without exceeding the stipulated radiotherapy doses in organs at risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemoradiotherapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anders Johnsson, MD, PhD, University Hospital Lund
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
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Endocrine System Diseases
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Biliary Tract Neoplasms
- Stomach Neoplasms
- Colorectal Neoplasms
- Urinary Bladder Neoplasms
- Pancreatic Neoplasms
- Gastrointestinal Neoplasms
- Intestinal Neoplasms
- Gallbladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- Version1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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