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

Lund University Hospital

Status and phase

Completed

Phase 2

Phase 1

Conditions

Bile Ductus Cancer

Gall Bladder Cancer

Pancreas Cancer

Stomach Cancer

Colorectal Cancer

Treatments

Other: oxaliplatin, capecitabine, radiotherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01016639

Version1

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No 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