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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323830
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : November 9, 2011
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center

May 8, 2006
May 10, 2006
November 9, 2011
October 2004
April 2008   (Final data collection date for primary outcome measure)
disease free survival [ Time Frame: 3-year ]
disease free survival
Complete list of historical versions of study NCT00323830 on Archive Site
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overall survival, recurrence rate, toxicity
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Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma
Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Gastric Cancer
  • Surgery
Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
Capecitabine, cisplatin + Radiotherapy (randomized)
  • Experimental: capecitabine/cisplatin/radiotherapy
    postoperative XP/RT
    Intervention: Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
  • Active Comparator: capecitabine/cisplatin
    postoperative XP
    Intervention: Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Won Ki Kang, Samsung Medical Center
Samsung Medical Center
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Principal Investigator: Won Ki Kang, MD Samsung Medical Center
Samsung Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP