Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

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Primary Purpose

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Epirubicin

Cisplatin

5-Fluorouracil (5-FU)

Radiation

About this trial

This is an interventional prevention trial for Stomach Cancer focused on measuring adjuvant chemoradiation, GE junction, epirubicin

Eligibility Criteria

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

Inclusion Criteria: Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible. Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected. The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging. Treatment must begin between day 20 and day 56 after the gastrectomy. ECOG performance status of 0,1 or 2 ANC > 1,500/ul and platelet count >100,000/ul Serum creatinine < 1.5mg/dl Total bilirubin < 2.0 mg/dl and AST < 3 x ULN Estimated caloric intake of 1500K calories per day or greater Exclusion Criteria: Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years Previous chemotherapy or radiotherapy Active infectious process Pregnant or lactating women Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease Uncontrolled serious medical or psychiatric condition Grade 2 or greater peripheral neuropathy at baseline

Sites / Locations

Massachusetts General Hospital
Brigham and Women's Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECF followed by 5-FU/RT followed by ECF

Arm Description

Outcomes

Primary Outcome Measures

To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.

Secondary Outcome Measures

Full Information

NCT ID

NCT00215514

First Posted

September 20, 2005

Last Updated

July 28, 2014

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00215514

Brief Title

Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Official Title

A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

September 2000 (undefined)

Primary Completion Date

November 2003 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.

Detailed Description

Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy. Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump. After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle. The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study. The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.

6. Conditions and Keywords

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

Stomach Cancer, Gastric Cancer, Gastro-esophageal Junction Cancer

Keywords

adjuvant chemoradiation, GE junction, epirubicin

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ECF followed by 5-FU/RT followed by ECF

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Intervention Description

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil (5-FU)

Intervention Description

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Intervention Type

Procedure

Intervention Name(s)

Radiation

Intervention Description

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Primary Outcome Measure Information:

Title

To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible. Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected. The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging. Treatment must begin between day 20 and day 56 after the gastrectomy. ECOG performance status of 0,1 or 2 ANC > 1,500/ul and platelet count >100,000/ul Serum creatinine < 1.5mg/dl Total bilirubin < 2.0 mg/dl and AST < 3 x ULN Estimated caloric intake of 1500K calories per day or greater Exclusion Criteria: Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years Previous chemotherapy or radiotherapy Active infectious process Pregnant or lactating women Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease Uncontrolled serious medical or psychiatric condition Grade 2 or greater peripheral neuropathy at baseline

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles S. Fuchs, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Stomach Cancer, Gastric Cancer, Gastro-esophageal Junction Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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