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A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

Thank you

Trial Information

A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus


- Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil
followed by chemoradiotherapy and possible surgical salvage in patients with resectable
locally advanced carcinoma of the esophagus or gastroesophageal junction.

- Determine the overall and disease-free survival of patients treated with this regimen.

- Determine the treatment-related toxicity of this regimen in these patients.

- Determine the tolerance to surgical salvage in patients treated with this regimen.

- Determine the morbidity and mortality of surgical salvage in patients treated with this

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours
beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel
IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and
34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence
of unacceptable toxicity.

- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV
continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients
concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82,
85-89, and 92-96.

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of
chemoradiotherapy may undergo salvage esophagectomy.

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Inclusion Criteria


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

- Primary (non-recurrent) disease

- Amenable to resection

- Stage greater than T1, N0 by endoscopic ultrasound

- Must be entirely confined to the esophagus or gastroesophageal junction and
periesophageal soft tissue

- Tumor may not extend more than 2 cm into the stomach

- No multiple primary carcinomas of the esophagus

- No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus

- No evidence of disseminated cancer

- Suggestion of liver metastases by positron emission tomography must be proven
negative by biopsy or other imaging studies

- Palpable supraclavicular nodes must be negative for cancer by biopsy

- Bronchoscopy required for lesions less than 26 cm from the incisors to exclude
tracheoesophageal fistula or invasion

- No celiac adenopathy greater than 2 cm



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute granulocyte 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 AND/OR

- Creatinine clearance at least 65 mL/min

- Calcium no greater than 11 mg/dL


- No uncontrolled heart disease

- No uncontrolled hypertension


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to comprehend study requirements and considered likely to comply with study

- No other malignancy within the past 5 years except curable nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No uncontrolled diabetes

- No hypersensitivity to E. coli-derived products


Biologic therapy

- Not specified


- More than 5 years since prior systemic chemotherapy

Endocrine therapy

- Not specified


- No prior chest or upper abdomen radiotherapy


- No prior esophageal or gastric surgery


- No concurrent photodynamic therapy

- No other concurrent investigational agents for esophageal carcinoma

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival rate at 1 year

Safety Issue:


Principal Investigator

Stephen G. Swisher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



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