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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer, Pancreas Cancer, Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Anders Johnsson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Lund

Authority:

Sweden: Medical Products Agency

Study ID:

Version1

NCT ID:

NCT01016639

Start Date:

June 2003

Completion Date:

July 2009

Related Keywords:

  • Stomach Cancer
  • Gall Bladder Cancer
  • Bile Ductus Cancer
  • Pancreas Cancer
  • Colorectal Cancer
  • Stomach cancer
  • Gall bladder cancer
  • Bile ductus cancer
  • Pancreas cancer
  • Colorectal cancer
  • Chemo radiotherapy
  • Phase I-II
  • Oxaliplatin
  • Capecitabine
  • Response
  • Urinary Bladder Neoplasms
  • Colorectal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms

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