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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323830
• Other study ID #: 2004-08-10
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2006
• Last updated: November 8, 2011
• Start date: October 2004
• Est. completion date: April 2011

Study information

• Verified date: November 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: April 2011
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma

2. = D2 resection

3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 ??, M1 lymph node ??)

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		3-year	No