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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00323830
First received: May 8, 2006
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Gastric Cancer
Surgery
 Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]

Enrollment: 458
Study Start Date: October 2004
Study Completion Date: April 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323830

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
  More Information

No publications 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     History of Changes
Other Study ID Numbers: 2004-08-10
Study First Received: May 8, 2006
Last Updated: November 8, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
gastric cancer
radiotherapy
postoperative therapy
chemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013