Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
18 Years
75 Years
Both
Gastric Cancer, Surgery
Trial Information
Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
Although gastrectomy is the only potentially curative treatment in gastric cancer patients,
the overall survival results remain unsatisfactory. The main factor accounting for high
mortality rate is the relapse after surgical resection. During the past few decades, the
principle of combined modality treatment has been developed and applied in practice for
various solid tumors and gastric cancer has not been an exception. In an attempt to prevent
recurrence and increase the cure rate of gastric cancer patients after surgery, multiple
studies using variable modalities have been undertaken. One of the landmark study in
adjuvant trials was the Intergroup study INT-0116, which reported a significant improvement
in survival with the use of chemoradiation therapy after gastric resection of stage Ib to IV
gastric cancers. Thereafter, the chemoradiation therapy has gained popularity and has been
increasingly recognized as a standard of care in U.S. Nevertheless, the result from
INT-0116 study has been challenged by the fact that the surgical treatment applied in the
trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases.
Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival
benefit in patients with extensive lymph node dissection.
It is still disputable if chemoradiotherapy after D2 can improve the results of D2 alone.
Thus, the assessment of the effect of adjuvant chemoradiotherapy in D2 resected gastric
cancer is essential.
Inclusion Criteria:
1. Histologically proven gastric adenocarcinoma
2. ≥ D2 resection
3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)
4. 18 ≤ age ≤ 75
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul,
haemoglobin ≥ 10g/dl)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent
Exclusion Criteria:
1. Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer
2. Active infection requiring antibiotics
3. Pregnant, lactating women
4. Psychiatric illness, epileptic disorders
5. Concurrent systemic illness not appropriate for chemotherapy
6. Resection margin (+)
7. Pathologic stage IA
8. History of other malignancy within 5 years except for non-melanoma skin cancer,
cervix in situ carcinoma
9. M1 lymph node (+)
10. D0, D1 resection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease free survival
Outcome Time Frame:
3-year
Safety Issue:
No
Principal Investigator
Won Ki Kang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
2004-08-10
NCT ID:
NCT00323830
Start Date:
October 2004
Completion Date:
April 2011
Related Keywords:
- Gastric Cancer
- Surgery
- gastric cancer
- radiotherapy
- postoperative therapy
- chemotherapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
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