Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer (CORGI)
Primary Purpose
Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
oxaliplatin, capecitabine, radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Cancer focused on measuring Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin, Capecitabine, Response
Eligibility Criteria
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
Sites / Locations
- Centralsjukhuset, Dept of Oncology
- University Hospital Lund
- University Hospital Malmö, Dept of Oncology
- Karolinska University Hospital
- Akademiska Sjukhuset
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01016639
First Posted
November 18, 2009
Last Updated
October 14, 2011
Sponsor
Lund University Hospital
Collaborators
Roche Pharma AG, Sanofi-Synthelabo
1. Study Identification
Unique Protocol Identification Number
NCT01016639
Brief Title
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
Acronym
CORGI
Official Title
Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Roche Pharma AG, Sanofi-Synthelabo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer, Pancreas Cancer, Colorectal Cancer
Keywords
Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin, Capecitabine, Response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemoradiotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
oxaliplatin, capecitabine, radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Johnsson, MD, PhD
Organizational Affiliation
University Hospital Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centralsjukhuset, Dept of Oncology
City
Karlstad
Country
Sweden
Facility Name
University Hospital Lund
City
Lund
Country
Sweden
Facility Name
University Hospital Malmö, Dept of Oncology
City
Malmö
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
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