Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach

Gastric Cancer Clinical Trial

Official title:

Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009880
• Other study ID #: RTOG-0113
• Secondary ID: CDR0000068420
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: July 17, 2013
• Start date: April 2001

Study information

• Verified date: July 2004
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 and radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.

Description:

OBJECTIVES:

• Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin, paclitaxel, and concurrent radiotherapy with or without fluorouracil.

• Compare the tolerance of these regimens by these patients.

• Compare the overall quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over 24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy. Patients with local disease progression after the first course proceed to chemoradiotherapy.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

• Arm II: Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1. Treatment continues every 3 weeks for 2 courses as in arm I.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36, and paclitaxel IV continuously over 96 hours on days 1-4, 8-11, 15-18, 22-25, 29-32, and 36-39.

Quality of life is assessed at baseline, within 1 week after radiotherapy, at 6 weeks after study completion, every 4 months for 1 year, every 6 months for 2 years, and then annually for 5 years.

Patients are followed within 8 weeks, every 4 months for 1 year, every 6 months for two years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study within 21 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

• Stage I-III (T1, N1, M0; T2-4, N any, M0)

• Supraclavicular or celiac lymph node involvement allowed

• Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue

• Cervical esophageal carcinoma allowed

• No tumor extension beyond 2 cm into stomach

• No multiple primary carcinomas of the esophagus

• No evidence of disseminated cancer

• No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi

• Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 150,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 65 mL/min

Cardiovascular:

• No uncontrolled heart disease

• No uncontrolled hypertension

Other:

• Total oral/enteral intake must be at least 1,700 kCal/day

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No uncontrolled diabetes

• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior chest radiotherapy

Surgery:

• No prior major esophageal surgery

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• cisplatin

• fluorouracil

• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Akron City Hospital at Summa Health System	Akron	Ohio
United States	Akron General's McDowell Cancer Center	Akron	Ohio
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Wendt Regional Cancer Center at Finley Hospital	Dubuque	Iowa
United States	Dale and Frances Hughes Cancer Center at Pocono Medical Center	East Stroudsburg	Pennsylvania
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	East Syracuse	New York
United States	Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center	Edgewood	Kentucky
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Community Memorial Hospital	Menomonee Falls	Wisconsin
United States	Baptist-South Miami Regional Cancer Program	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Cancer Center at Ball Memorial Hospital	Muncie	Indiana
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Tulane Cancer Center at Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Leavey Cancer Center at Northridge Hospital Medical Center	Northridge	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Cancer Center at Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Atlantic City Medical Center - Mainland Division	Pomona	New Jersey
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Dixie Regional Medical Center	Saint George	Utah
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Union Hospital	Terre Haute	Indiana
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the — View Citation

Komaki R, Winter K, Ajani A, et al.: A randomized phase II study of two paclitaxel-based chemoradiotherapy regimens for patients with the non-operative esophageal carcinoma (RTOG 0113). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-142, S79-80

Komaki R, Winter K, Ajani J: Non-operative therapy of local-regional carcinoma of the esophagus: a randomized phase II study of two paclitaxel-based chemoradiotherapy regimens (RTOG 0113). [Abstract] The American Radium Society 89th Annual Meeting, May 5-