Stomach Cancer
Conditions
Keywords
stomach cancer, adjuvant chemotherapy, mitomycin, cisplatin, doxifluridine
Brief summary
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
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 the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.
Interventions
DRUGcisplatin, mitomycin-C, doxifluridine
Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Sponsors
Ulsan University Hospital
Hallym University Medical Center
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically proven gastric adenocarcinoma * Grossly serosa invasion of primary tumor is suspicious * 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: Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate bone marrow function (white blood cell counts ≥ 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, aspartate aminotransferase (AST)/alanine aminotransferase (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 computed tomography (CT) * Systemic disease which interfere the administration of chemotherapy * Postoperative pathologic stage IA, IB * Postoperative pathology indicates that resection margin is involved * Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free Survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Profile (According to NCI CTC Version 2.0) | up to 1 year | Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will. |
| Overall Survival | 3 years | — |
Countries
South Korea
Participant flow
Pre-assignment details
Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Mitomycin and Short-term Fluoropyrimidine Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) | 258 |
| iceMFP Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine | 263 |
| Total | 521 |
Baseline characteristics
| Characteristic | iceMFP | Mitomycin and Short-term Fluoropyrimidine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 46 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 224 Participants | 212 Participants | 436 Participants |
| Age, Continuous | 52.23 years STANDARD_DEVIATION 11.016 | 53.87 years STANDARD_DEVIATION 10.093 | 53.04 years STANDARD_DEVIATION 10.591 |
| Region of Enrollment Korea, Republic of | 263 participants | 258 participants | 521 participants |
| Sex: Female, Male Female | 88 Participants | 82 Participants | 170 Participants |
| Sex: Female, Male Male | 175 Participants | 176 Participants | 351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 230 / 258 | 251 / 263 |
| serious Total, serious adverse events | 0 / 258 | 0 / 263 |
Outcome results
Primary
Relapse-free Survival
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitomycin and Short-term Fluoropyrimidine | Relapse-free Survival | 50.0 percentage of participants |
| iceMFP | Relapse-free Survival | 60.2 percentage of participants |
Secondary
Overall Survival
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitomycin and Short-term Fluoropyrimidine | Overall Survival | 59.6 percentage of participants |
| iceMFP | Overall Survival | 71.2 percentage of participants |
Secondary
Toxicity Profile (According to NCI CTC Version 2.0)
Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.
Time frame: up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitomycin and Short-term Fluoropyrimidine | Toxicity Profile (According to NCI CTC Version 2.0) | 13 participants |
| iceMFP | Toxicity Profile (According to NCI CTC Version 2.0) | 30 participants |