search
Back to results

Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
paclitaxel
surgical procedure
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage II gastric cancer, stage III gastric cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the esophagus, gastroesophageal junction or cardia T2N1, T3 any N, T4 any N, and negative margins Proximal and distal margins of resection must be negative No metastases Must be within 4-12 weeks from date of surgery and clinically without evidence of local-regional or distant recurrence PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 120,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Renal: Creatinine within institutional normal limits Cardiovascular: No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No myocardial infarction within 6 months No clinically significant conduction system abnormalities such as second or third degree heart block or bundle branch block Neurologic: No symptomatic peripheral neuropathy No psychosis Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No significant hearing loss No concurrent uncontrolled infection or medical illness No concurrent malignancies within 3 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No history of allergy to drugs containing cremophor No hypersensitivity to E. coli derived proteins PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Chicago (Lakeside)
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Central Illinois
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Ochsner
  • New England Medical Center Hospital
  • Beth Israel Deaconess Medical Center
  • CCOP - Ann Arbor Regional
  • CCOP - Metro-Minnesota
  • CCOP - Northern New Jersey
  • Albert Einstein Comprehensive Cancer Center
  • Veterans Affairs Medical Center - New York
  • Kaplan Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
  • Allegheny University Hospitals- Hahnemann
  • University of Pennsylvania Cancer Center
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • CCOP - MainLine Health
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • Veterans Affairs Medical Center - San Juan
  • Pretoria Academic Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 21, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003237
Brief Title
Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
Official Title
Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 1998 (Actual)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of paclitaxel and cisplatin, given after surgery in treating patients with cancer of the esophagus or stomach.
Detailed Description
OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving post-operative adjuvant paclitaxel plus cisplatin. OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study. Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months thereafter. PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
stage II gastric cancer, stage III gastric cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the esophagus, gastroesophageal junction or cardia T2N1, T3 any N, T4 any N, and negative margins Proximal and distal margins of resection must be negative No metastases Must be within 4-12 weeks from date of surgery and clinically without evidence of local-regional or distant recurrence PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 120,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Renal: Creatinine within institutional normal limits Cardiovascular: No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No myocardial infarction within 6 months No clinically significant conduction system abnormalities such as second or third degree heart block or bundle branch block Neurologic: No symptomatic peripheral neuropathy No psychosis Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No significant hearing loss No concurrent uncontrolled infection or medical illness No concurrent malignancies within 3 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No history of allergy to drugs containing cremophor No hypersensitivity to E. coli derived proteins PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene A. Forastiere, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Lakeside)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Central Illinois
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Veterans Affairs Medical Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Kaplan Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Allegheny University Hospitals- Hahnemann
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
15542799
Citation
Armanios M, Xu R, Forastiere AA, Haller DG, Kugler JW, Benson AB 3rd; Eastern Cooperative Oncology Group. Adjuvant chemotherapy for resected adenocarcinoma of the esophagus, gastro-esophageal junction, and cardia: phase II trial (E8296) of the Eastern Cooperative Oncology Group. J Clin Oncol. 2004 Nov 15;22(22):4495-9. doi: 10.1200/JCO.2004.06.533. Erratum In: J Clin Oncol. 2008 Aug 1;26(22):3819.
Results Reference
result

Learn more about this trial

Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach

We'll reach out to this number within 24 hrs