CORGI: Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Sponsor

Lund University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01016639

Collaborator

Roche Pharma AG (Industry), Sanofi-Synthelabo (Industry)

106

Enrollment

Locations

Arm

Duration (Months)

21.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Cancer Gall Bladder Cancer Bile Ductus Cancer Pancreas Cancer Colorectal Cancer	Other: oxaliplatin, capecitabine, radiotherapy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemoradiotherapy	Other: oxaliplatin, capecitabine, radiotherapy

Arm

Intervention/Treatment

Experimental: Chemoradiotherapy

Other: oxaliplatin, capecitabine, radiotherapy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Centralsjukhuset, Dept of Oncology	Karlstad	Sweden
2	University Hospital Lund	Lund	Sweden
3	University Hospital Malmö, Dept of Oncology	Malmö	Sweden
4	Karolinska University Hospital	Stockholm	Sweden
5	Akademiska Sjukhuset	Uppsala	Sweden