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Phase II Trial of Preoperative Combined Modality Therapy for Localized Esophageal Carcinoma: Cisplatin-Paclitaxel Followed by Radiation Therapy With Concurrent Cisplatin and Paclitaxel

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

Phase II Trial of Preoperative Combined Modality Therapy for Localized Esophageal Carcinoma: Cisplatin-Paclitaxel Followed by Radiation Therapy With Concurrent Cisplatin and Paclitaxel

OBJECTIVES: I. Determine the response rate to preoperative induction paclitaxel/cisplatin
followed by concurrent paclitaxel/cisplatin and radiotherapy in locally advanced esophageal
cancer. II. Determine the toxic effects, including surgical morbidity and mortality, and
patient survival after this combination therapy. III. Monitor the quality of life of
patients receiving this combination therapy. IV. Determine c Jun oncogene and thymidylate
synthase expression and p53 mutation before and after this combination therapy.

OUTLINE: This is an open label, multicenter study. (Adenocarcinoma stratum closed) Patients
receive of induction chemotherapy consisting of paclitaxel IV over 3 hours followed by
cisplatin IV on days 1 and 22. Patients then receive radiation therapy 5 days a week for 6
weeks, along with paclitaxel and cisplatin 4 days a week. Patients undergo surgery (complete
or partial resection) within 4-8 weeks of completion of the chemoradiotherapy. Patients are
followed every 3 months for the first 2 years, every 6 months for the next 2 years, and
annually thereafter. Quality of life is assessed for the first year of follow up only.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for each histology
(adenocarcinoma, squamous carcinoma) within 18-24 months. (Adenocarcinoma stratum closed)

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma or adenocarcinoma
of the thoracic esophagus (adenocarcinoma stratum closed) Locally advanced and surgically
resectable (T2-4 N0-1 M0) T1 N1 tumors are eligible, T1 N0 tumors and in situ carcinoma
are not eligible No cervical esophageal tumors No brain, pulmonary, liver, bone, lymph
node (cervical or supraclavicular) or other distant metastases No positive cytology of the
pleura, pericardium, or peritoneum No invasion of the tracheobronchial tree or presence of
tracheoesophageal fistula

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3
Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal:
Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL Cardiovascular: No
New York Heart Association class III/IV heart disease No history of active angina No
myocardial infarction within 6 months No history of significant ventricular arrhythmia
requiring medication No history of clinically significant conduction system abnormality
Pulmonary: FEV1 at least 1.2 L Other: Not pregnant or nursing Negative pregnancy test No
serious concurrent infections or uncontrolled nonmalignant medical illnesses No psychosis
No clinically significant hearing loss No recurrent laryngeal nerve or phrenic nerve
paralysis No concurrent active malignancy except nonmelanomatous skin cancer or carcinoma
in situ of the cervix Prior malignancies without evidence of disease for at least 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy No other concurrent radiotherapy Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

February 2005

Related Keywords:

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



Memorial Sloan-Kettering Cancer Center New York, New York  10021