Trial of Adjuvant Chemotherapy for Gastric Cancer

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

cisplatin, mitomycin-C, doxifluridine

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring stomach cancer, adjuvant chemotherapy, mitomycin, cisplatin, doxifluridine

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mitomycin-C, Doxifluridine

Mitomycin-C, Doxifluridine, Cisplatin

Arm Description

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)

Outcomes

Primary Outcome Measures

Relapse-free Survival

Secondary Outcome Measures

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.

Overall Survival

Full Information

NCT ID

NCT00296322

First Posted

February 24, 2006

Last Updated

January 6, 2020

Sponsor

Asan Medical Center

Collaborators

Ulsan University Hospital, Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00296322

Brief Title

Trial of Adjuvant Chemotherapy for Gastric Cancer

Official Title

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

Collaborators

Ulsan University Hospital, Hallym University Medical Center

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Cancer

Keywords

stomach cancer, adjuvant chemotherapy, mitomycin, cisplatin, doxifluridine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

528 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitomycin-C, Doxifluridine

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Mitomycin-C, Doxifluridine, Cisplatin

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

cisplatin, mitomycin-C, doxifluridine

Intervention Description

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)

Primary Outcome Measure Information:

Title

Relapse-free Survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Toxicity Profile (According to NCI CTC Version 2.0)

Description

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

Title

Overall Survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon-Koo Kang, M.D.,Ph.D.

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Stomach Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial