Status:
UNKNOWN
Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)
Lead Sponsor:
Dutch Colorectal Cancer Group
Collaborating Sponsors:
The Netherlands Cancer Institute
Roche Pharma AG
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer....
Detailed Description
The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because most patients in the Western world present with advanced stages long term survival is found in about 25%, w...
Eligibility Criteria
Inclusion
- Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in the stomach
- WHO \< 2
- Age ≥18 yrs
- Operable gastric cancer
- No prior abdominal radiotherapy or chemotherapy
- Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
- Start treatment within 10 working days after registration
- Written informed consent
Exclusion
- T1N0 disease (endoscopic ultrasound)
- Distant metastases
- Inoperable patients; due to technical surgery-related factors or general condition
- Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri.
- Solitary functioning kidney that will be within the radiation field
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
- Uncontrolled (bacterial) infections
- Significant cardiac disorders
- Continuous use of immunosuppressive agents
- Concurrent use of the antiviral agent sorivudine or chemically related analogues
- Hearing loss \> CTC grade 1
- Neurotoxicity \> CTC grade 1
Key Trial Info
Start Date :
January 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
788 Patients enrolled
Trial Details
Trial ID
NCT00407186
Start Date
January 11 2007
End Date
December 1 2025
Last Update
October 10 2017
Active Locations (1)
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1
Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX