Status:
COMPLETED
Study of Adjuvant Radiochemotherapy for Gastric Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25 fractions) versus surgery a...
Eligibility Criteria
Inclusion
- R0 resection (no microscopic residual) of adenocarcinoma of stomach or gastroesophageal (GE) junction, prior to starting chemotherapy and radiation
- Tumor must not extend more than 2 cm along the esophagus; bulk of the tumor must be in the stomach.
- Adequate pre-operative cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
- International Union Against Cancer (UICC)/American Joint Committee on Cancer (AJCC) Stage IB - IV, excluding patients with metastatic disease (T1N1, T2N0 to T4N1, N2, and any T, N3). T2N0 eligible only if disease extends beyond muscularis propria.
- No previous abdominal radiotherapy or contraindication to radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
- Adequate major organ function
- Nutritional intake of at least 1500 calories per day at nutrition assessment
- Treatment started within 20-90 days post-op of surgery date.
- Informed consent
Exclusion
- Less than 70 years of age
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00188266
Start Date
August 1 2002
End Date
August 18 2017
Last Update
September 20 2017
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9