Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma

Study Overview
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Brief Summary
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The objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.

Detailed Description
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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.

Official Title
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Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma

Conditions
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Gastric Cancer, Surgery

Intervention / Treatment
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* Drug: Capecitabine, cisplatin, Radiotherapy (+/-)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven gastric adenocarcinoma ≥ D2 resection Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외) 18 ≤ age ≤ 75 ECOG 0-2 No distant metastasis Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl) Adequate renal functions(serum creatinine ≤ 1.5mg/dl) liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 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 (+) Pathologic stage IA History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma M1 lymph node (+) D0, D1 resection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: capecitabine/cisplatin/radiotherapy<br>postoperative XP/RT | Drug: Capecitabine, cisplatin, Radiotherapy (+/-)<br>* Capecitabine, cisplatin + Radiotherapy (randomized)<br>|
| Active Comparator: capecitabine/cisplatin<br>postoperative XP | Drug: Capecitabine, cisplatin, Radiotherapy (+/-)<br>* Capecitabine, cisplatin + Radiotherapy (randomized)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, radiotherapy, postoperative therapy, chemotherapy