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


Phase 2
N/A
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jaffer A. Ajani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068420

NCT ID:

NCT00009880

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • adenocarcinoma of the stomach
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Community Medical CenterToms River, New Jersey  08755
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
SUNY Downstate Medical CenterBrooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Leavey Cancer Center at Northridge Hospital Medical CenterNorthridge, California  91325
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Union HospitalTerre Haute, Indiana  47804
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Atlantic City Medical Center - Mainland DivisionPomona, New Jersey  08240
Akron City Hospital at Summa Health SystemAkron, Ohio  44304
Cancer Center at Paoli Memorial HospitalPaoli, Pennsylvania  19301
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Akron General's McDowell Cancer CenterAkron, Ohio  44302
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301