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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

May 8, 2006
November 8, 2011
October 2004
April 2008   (final data collection date for primary outcome measure)
disease free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
disease free survival
Complete list of historical versions of study NCT00323830 on ClinicalTrials.gov Archive Site
Not Provided
overall survival, recurrence rate, toxicity
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 (+/-)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
458
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00323830
2004-08-10
Not Provided
Won Ki Kang, Samsung Medical Center
Samsung Medical Center
Not Provided
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