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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00323830
• Collaborator: (none)
• Enrollment: 458
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; Surgery	Drug: Capecitabine, cisplatin, Radiotherapy (+/-)	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 458 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: capecitabine/cisplatin/radiotherapy postoperative XP/RT	Drug: Capecitabine, cisplatin, Radiotherapy (+/-); Capecitabine, cisplatin + Radiotherapy (randomized)
Active Comparator: capecitabine/cisplatin postoperative XP	Drug: Capecitabine, cisplatin, Radiotherapy (+/-); Capecitabine, cisplatin + Radiotherapy (randomized)

Outcome Measures

Primary Outcome Measures

1. disease free survival [3-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Won Ki Kang, MD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT00323830
• Other Study ID Numbers: 2004-08-10
• First Posted: May 10, 2006
• Last Update Posted: Nov 9, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center: gastric cancer; radiotherapy; postoperative therapy; chemotherapy
• Additional relevant MeSH terms: Adenocarcinoma; Stomach Neoplasms; Capecitabine

Study Results

No Results Posted as of Nov 9, 2011