Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00296322
Other study ID # AMC0102
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2001
Est. completion date March 2010

Study information

Verified date January 2020
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date March 2010
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cisplatin, 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)

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Asan Medical Center Hallym University Medical Center, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse-free Survival 3 years
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. up to 1 year
Secondary Overall Survival 3 years
See also
  Status Clinical Trial Phase
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT02604979 - The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study N/A
Active, not recruiting NCT00394433 - Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer Phase 2
Completed NCT00201747 - Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer Phase 2
Completed NCT00215514 - Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma Phase 0
Recruiting NCT04486651 - HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer Phase 3
Recruiting NCT05415475 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors Phase 1
Recruiting NCT04526470 - Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer Phase 1/Phase 2
Completed NCT01257711 - A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer N/A
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Withdrawn NCT03704077 - An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Phase 2
Recruiting NCT05489250 - The PLATON Network
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Completed NCT02547064 - Effect of Modified Stylet Angulation on the Intubation With GlideScope® N/A
Withdrawn NCT00800969 - Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach Phase 2
Recruiting NCT04215861 - Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
Recruiting NCT06199895 - Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer Phase 2
Recruiting NCT01038154 - Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer Phase 4
Active, not recruiting NCT03760822 - Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients Phase 2