Trial of Adjuvant Chemotherapy for Gastric Cancer
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Purpose
This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Cancer |
Drug: mitomycin, cisplatin, doxifluridine |
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: | A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma |
- Relapse free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Every cycle of chemotherapy according to National Cancer Institute Common Toxicity Criteria version 2.0
| Enrollment: | 881 |
| Study Start Date: | February 2002 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mf
Control arm
|
Drug: mitomycin, cisplatin, doxifluridine
Mf: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) MFP: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
|
Experimental: MFP
Experimental arm
|
Drug: mitomycin, cisplatin, doxifluridine
Mf: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) MFP: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
Detailed Description:
Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.
This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically proven gastric adenocarcinoma
- Curative resection was done
- stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
- age: 18-69 years old
- Performance status: ECOG 0-2
- Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
- Adequate renal function (serum creatinine≤ 1.5)
- Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)
- Written informed consent was signed by the patient
Exclusion Criteria:
- Previous chemotherapy or radiotherapy
- Active ongoing infection which antibiotic treatment is needed
- Pregnant or lactating women
- Psychosis or convulsion disorder
- Ascites in preoperative abdomen CT
- Systemic disease which interfere the administration of chemotherapy
- Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Contacts and Locations| Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Principal Investigator: | Yoon-Koo Kang, M.D.,Ph.D. | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Yoon-Koo Kang, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00296335 History of Changes |
| Other Study ID Numbers: | AMC-ONCGI-0204 |
| Study First Received: | February 24, 2006 |
| Last Updated: | January 5, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Asan Medical Center:
|
Stomach cancer Adjuvant chemotherapy Mitomycin Cisplatin Doxifluridine |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Adjuvants, Immunologic Mitomycins Mitomycin Doxifluridine Cisplatin Floxuridine Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Radiation-Sensitizing Agents Immunosuppressive Agents Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 16, 2013