Phase III Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection
18 Years
75 Years
Both
Gastric Cancer
Trial Information
Phase III Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection
Gastric cancer is one of the most common malignancies in China. Complete surgical resection
is the only potentially curative therapy available to patients with gastric cancer. However,
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 gastric cancer.
Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a
significant improvement in overall and disease-free survival according to Intergroup Trial
0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116
study had 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. In ARTIST study, the addition of concurrent
capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not
significantly reduce recurrence after curative resection and D2 lymph node dissection in
gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there
was a statistically significant prolongation in disease-free survival in the concurrent
treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study
showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for
stage II or III patients after D2 surgery could achieve a significant survival benefit. The
standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus,
the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric
cancer is essential.
Inclusion Criteria:
- Histologically proven gastric cancer; ≥ D2 resection
- Stage T3、4/N+
- 18 ≤ age ≤ 75
- Eastern Cooperative Oncology Group 0-2
- No distant metastasis
- Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥
100,000/ul, haemoglobin≥ 10g/dl)
- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate
aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
- Written informed consent
Exclusion Criteria:
- Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;
- Active infection requiring antibiotics;
- Pregnant, lactating women;
- Psychiatric illness, epileptic disorders;
- Concurrent systemic illness not appropriate for chemotherapy;
- Resection margin (+);
- History of other malignancy within 5 years except for non-melanoma skin cancer,
cervix in situ carcinoma;
- D0, D1 resection;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
disease free survival
Outcome Time Frame:
3-year
Safety Issue:
No
Principal Investigator
congying xie, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wenzhou Medical University
Authority:
China: Food and Drug Administration
Study ID:
WZMC-12068
NCT ID:
NCT01711242
Start Date:
January 2012
Completion Date:
December 2017
Related Keywords:
- Gastric Cancer
- gastric cancer
- radiotherapy
- postoperative therapy
- chemotherapy
- Stomach Neoplasms
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