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Chemotherapy and Radiation Th...

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

Last Updated: 2020-05-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2016-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.

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Detailed Description

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OBJECTIVES:

* Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
* Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
* Correlate the expression of putative prognostic markers (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27, COX-2, and c-erbB-2) with overall survival of patients treated with these regimens.
* Correlate specific germline polymorphisms related to chemotherapy metabolism and resistance (including UGT2B7 \[epirubicin\], GST \[cisplatin\], ERCCI \[cisplatin\], XRCC1 \[cisplatin\], TS \[5-FU\], DPD \[5-FU\], and EGFR polymorphisms) with treatment-related toxicity and overall survival of these patients.
* Correlate serum levels of insulin-like growth factor-1 (IGF-1), IGF-2, and IGF-binding protein 3 with overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3.
* Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.

Conditions

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Esophageal Cancer Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.

Group Type ACTIVE_COMPARATOR

fluorouracil

Intervention Type DRUG

Given IV

leucovorin calcium

Intervention Type DRUG

Given IV

radiation therapy

Intervention Type RADIATION

Given 5 days a week for 5 weeks

Arm II

Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

Given IV

epirubicin hydrochloride

Intervention Type DRUG

Given IV

fluorouracil

Intervention Type DRUG

Given IV

radiation therapy

Intervention Type RADIATION

Given 5 days a week for 5 weeks

Interventions

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cisplatin

Given IV

Intervention Type DRUG

epirubicin hydrochloride

Given IV

Intervention Type DRUG

fluorouracil

Given IV

Intervention Type DRUG

leucovorin calcium

Given IV

Intervention Type DRUG

radiation therapy

Given 5 days a week for 5 weeks

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent.

1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.
* Patients can have stages IB if there is evidence of either node-positive (N1) disease or tumor extension beyond the muscularis propria (i.e., T1, N1, M0 patients are eligible but patients with T2, N0, M0 are allowed only if there is extension beyond the muscularis propria).
* Patients can have stages II, IIIA, IIIB or stage IV with M0 (i.e., T4N2M0).
* Stages 0, IA, or any stage with M1 are not allowed. (see Appendix I for TNM staging guide).

1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.
2. Prior Therapy

2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years.

2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
3. Patient Characteristics

3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.

3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration.

3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy.

3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study.

3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.
* The effects of therapeutic radiotherapy are known to be teratogenic.
* The effects of Epirubicin, Cisplatin, and 5-FU on a developing human fetus at the recommended therapeutic dose are less well known.
* For this reason and because DNA alkylating agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
* Should a woman become pregnant or suspect she is pregnant while participating on this study, she should inform her treating physician immediately. Because the risk of toxicity in nursing infants secondary to Epirubicin, Cisplatin, and 5-FU treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued.

3.6 Patients with any of the following cardiac conditions are ineligible:
* Uncontrolled high blood pressure
* Unstable angina
* Symptomatic congestive heart failure
* Myocardial infarction \< 6 months prior to registration
* Serious uncontrolled cardiac arrhythmia
* New York Heart Association classification III or IV.

3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent.

3.8 Patients with active infectious process are ineligible.

3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
4. Required Initial Laboratory Values:

* Granulocytes ≥ 1,500/μl
* Platelet count ≥ 100,000/μl
* Creatinine ≤ 1.5 mg/dl
* Bilirubin ≤ 2.0 mg/dl
* AST ≤ 3x upper limits of normal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Fuchs, MD, MPH

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

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Regional Medical Center

Anniston, Alabama, United States

Site Status

Providence Cancer Center at Providence Hospital

Mobile, Alabama, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Eden Medical Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

Monterey, California, United States

Site Status

Camino Medical Group - Treatment Center

Mountain View, California, United States

Site Status