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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
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

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


- 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

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

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


- 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



- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


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

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

- Hemoglobin at least 10 g/dL


- Not specified


- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 65 mL/min


- No uncontrolled heart disease

- No uncontrolled hypertension


- 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


Biologic therapy:

- Not specified


- No prior systemic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- No prior chest radiotherapy


- No prior major esophageal surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jaffer A. Ajani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




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



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