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

NCT ID: NCT00323830

Last Updated: 2011-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2011-04-30

Brief Summary

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

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.

Conditions

Gastric Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

capecitabine/cisplatin/radiotherapy

postoperative XP/RT

Group Type: EXPERIMENTAL

Capecitabine, cisplatin, Radiotherapy (+/-)

Intervention Type: DRUG

Capecitabine, cisplatin + Radiotherapy (randomized)

capecitabine/cisplatin

postoperative XP

Group Type: ACTIVE_COMPARATOR

Capecitabine, cisplatin, Radiotherapy (+/-)

Intervention Type: DRUG

Capecitabine, cisplatin + Radiotherapy (randomized)

Interventions

Capecitabine, cisplatin, Radiotherapy (+/-)

Capecitabine, cisplatin + Radiotherapy (randomized)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Ki Kang

Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won Ki Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.

Reference Type: DERIVED

PMID: 25559811 (View on PubMed)

Other Identifiers

2004-08-10

Identifier Type: -

Identifier Source: org_study_id