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Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach Clinical research trials and Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach. Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach

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



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

For Condition: Esophageal Cancer,Gastric Cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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. - 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. - 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JafferAjani,  Study Chair,  M.D. Anderson Cancer Center

Strecker Cancer Center at Marietta Memorial Hospital *Recruiting*
Marietta,  Ohio,  45750-1635
United States
Recruiting Contact  Person 740-374-1400

Delaware County Memorial Hospital *Recruiting*
Drexel Hill,  Pennsylvania,  19026
United States
Recruiting Rachelle  Lanciano 610-284-8240

MD Anderson Cancer Center Orlando *Recruiting*
Orlando,  Florida,  32806-2134
United States
Recruiting Alan  Forbes 407-643-3800

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111
United States
Recruiting Benjamin  Movsas 215-728-3631

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-3000
United States
Recruiting Nayana  Vora 626-359-8111

Ball Memorial Hospital Cancer Center *Recruiting*
Muncie,  Indiana,  47303-3499
United States
Recruiting Anthony  Tilmans 765-747-3827

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Paul  Sperduto 952-993-1517

Bryn Mawr Hospital *Recruiting*
Bryn Mawr,  Pennsylvania,  19010
United States
Recruiting Contact  Person 610-526-3686

Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee,  Wisconsin,  53295
United States
Recruiting Roger  Byhardt 414-384-2000 ext. 2585

CCOP - Toledo Community Hospital *Recruiting*
Toledo,  Ohio,  43623-3456
United States
Recruiting Paul  Schaefer 419-843-6147

University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195-6043
United States
Recruiting David  Schwartz 206-768-5356

State University of New York Health Science Center at Brooklyn *Recruiting*
Brooklyn,  New York,  11203
United States
Recruiting Marvin  Rotman 718-270-2181

Reading Hospital and Medical Center *Recruiting*
Reading,  Pennsylvania,  19612-6052
United States
Recruiting Albert  Yuen 610-988-8067

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114-4199
United States
Recruiting James  Wheeler 402-354-4104

Monmouth Medical Center *Recruiting*
Long Branch,  New Jersey,  07740-6395
United States
Recruiting Smitha  Gollamudi 732-923-6890

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

Foundation for Cancer Research and Education *Recruiting*
Phoenix,  Arizona,  85013
United States
Recruiting David  Brachman 602-274-4484

Lankenau Cancer Center at Lankenau Hospital *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Contact  Person 215-642-4800

Allegheny General Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15212
United States
Recruiting David  Parda 412-359-8084

Pocono Cancer Center *Recruiting*
East Stroudsburg,  Pennsylvania,  18301
United States
Recruiting Michael  Greenberg 570-476-3488

Akron City Hospital *Recruiting*
Akron,  Ohio,  44304
United States
Recruiting William  Demas 330-375-3557

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting William  Sause 801-408-1146

Methodist Medical Center of Illinois *Recruiting*
Peoria,  Illinois,  61636
United States
Recruiting Revathi  Swaminathan 309-672-5700

Memorial Hospital of South Bend *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Contact  Person 574-234-9041

Community Medical Center *Recruiting*
Toms River,  New Jersey,  08755
United States
Recruiting Bong  Chang 732-557-8148

Adena Regional Medical Center *Recruiting*
Chillicothe,  Ohio,  45601
United States
Recruiting Contact  Person 740-779-7500

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse,  New York,  13217
United States
Recruiting N.  Mariados 315-472-7504

McKay-Dee Hospital Center *Recruiting*
Ogden,  Utah,  84403
United States
Recruiting Contact  Person 801-627-2800

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Elizabeth  Gore 414-805-4465

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Adir  Ludin 216-844-5432

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Walter  Curran 215-955-6700

Utah Valley Regional Medical Center - Provo *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Tarlton  Blair 801-373-7850 ext. 2480

St. Luke's Hospital Cancer Center *Recruiting*
Bethlehem,  Pennsylvania,  18015
United States
Recruiting Nimisha  Deb 610-954-4300

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Ronald  McGarry 317-274-2524

Leavey Cancer Center at Northridge Hospital Medical Center *Recruiting*
Northridge,  California,  91328
United States
Recruiting Contact  Person 818-885-8500

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Michael  Samuels 305-674-2625

Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15219
United States
Recruiting Michael  Dougherty 412-232-7862

Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Mohan  Suntharalingam 410-328-6080

CCOP - MainLine Health *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Albert  DeNittis 610-645-2433

Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville,  Florida,  32610-0385
United States
Recruiting William  Mendenhall 352-265-0287

Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro,  North Carolina,  27533
United States
Recruiting Contact  Person 919-736-1110

Atlantic City Medical Center *Recruiting*
Pomona,  New Jersey,  08240
United States
Recruiting Jorge  Cassir 609-652-3417

Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque,  Iowa,  52001
United States
Recruiting Thomas  Lally 319-589-2468

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Miljenko  Pilepich 877-590-5995

Mount Carmel West Hospital *Recruiting*
Columbus,  Ohio,  43222
United States
Recruiting Contact  Person 614-234-5000

Paoli Memorial Hospital *Recruiting*
Paoli,  Pennsylvania,  19301-1792
United States
Recruiting Contact  Person 610-648-1637

Union Hospital *Recruiting*
Terre Haute,  Indiana,  47804
United States
Recruiting Contact  Person 812-238-7646

Dixie Regional Medical Center *Recruiting*
St. George,  Utah,  84770
United States
Recruiting Ray  Richards 801-688-4175

Baptist Hospital of Miami *Recruiting*
Miami,  Florida,  33256-2110
United States
Recruiting Andre  Abitbol 305-596-6566

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Judith  Figura 412-578-1923

Waukesha Memorial Hospital Regional Cancer Center *Recruiting*
Waukesha,  Wisconsin,  53188
United States
Recruiting Wingate  Clapper 262-928-2439

Mobile Infirmary Medical Center *Recruiting*
Mobile,  Alabama,  36652-2144
United States
Recruiting Contact  Person 251-435-2400

Fairfield Medical Center *Recruiting*
Lancaster,  Ohio,  43130
United States
Recruiting Contact  Person 740-687-8000

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Contact  Person 808-586-2979

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Community Memorial Hospital *Recruiting*
Menomonee Falls,  Wisconsin,  53051
United States
Recruiting Colleen  Lawton 262-251-1000

Cottonwood Hospital Medical Center *Recruiting*
Murray,  Utah,  84107
United States
Recruiting Contact  Person 801-314-5300

All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine,  Wisconsin,  53405
United States
Recruiting James  Taylor 262-687-5000

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Licking Memorial Hospital *Recruiting*
Newark,  Ohio,  43055-2899
United States
Recruiting Contact  Person 614-344-0331

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting Lawrence  Berk 614-566-9506

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112-2699
United States
Recruiting Ellen  Zakris 504-568-5151

Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Ronald  McGarry 317-274-2525

St. Elizabeth Medical Center *Recruiting*
Edgewood,  Kentucky,  41017
United States
Recruiting Michael  Cross 859-344-2238

Grady Memorial Hospital *Recruiting*
Delaware,  Ohio,  43015
United States
Recruiting Contact  Peson 740-368-5383

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

Akron General Medical Center *Recruiting*
Akron,  Ohio,  44302
United States
Recruiting Mitchell  Fromm 330-296-5019

University of Utah Health Sciences Center *Recruiting*
Salt Lake City,  Utah,  84132
United States
Recruiting Cherie  Hayostek 801-585-3593


Additional Information:
Study ID Numbers:
  CDR0000068420;  RTOG-E-0113
Study Start Date: 
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009880

Other Gastric Cancer Studies:
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2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer

3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

4. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer

5. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer

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