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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

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 3-year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323830

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Won Ki Kang, MD Samsung Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center Identifier: NCT00323830    
Other Study ID Numbers: 2004-08-10
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011
Keywords provided by Won Ki Kang, Samsung Medical Center:
gastric cancer
postoperative therapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action