Bile Ductus Cancer, Colorectal Cancer, Gall Bladder Cancer, Pancreas Cancer, Stomach Cancer
Conditions
Keywords
Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin, Capecitabine, Response
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.
Interventions
Sponsors
Roche Pharma AG
Sanofi-Synthelabo
Lund University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Sweden
Outcome results
None listed