Clinical trial NCT00323830: Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma
Official title: Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Surgery
Keywords: gastric cancer
radiotherapy
postoperative therapy
chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2006-05-10
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disease free survival
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ki Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.