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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer; Surgery

Treatments: Drug: Capecitabine, cisplatin, Radiotherapy (+/-)

Study type: Interventional

Funder types: Other

Identifiers

NCT00323830

2004-08-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 458 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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458 participants in 2 patient groups

capecitabine/cisplatin/radiotherapy

Experimental group

Description:

postoperative XP/RT

Treatment:

Drug: Capecitabine, cisplatin, Radiotherapy (+/-)

capecitabine/cisplatin

Active Comparator group

Description:

postoperative XP

Treatment:

Drug: Capecitabine, cisplatin, Radiotherapy (+/-)