Combination Chemotherapy, Radiation Therapy and Surgery in Treating Patients With Cancer of the Esophagus

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003087
• Other study ID #: 97-088
• Secondary ID: CDR0000065787NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 24, 2013
• Start date: August 1997
• Est. completion date: February 2005

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 more than one drug with radiation therapy before surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients with cancer of the esophagus that can be surgically removed.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 allowed

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 specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• cisplatin

• paclitaxel

Procedure:
• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bains MS, Stojadinovic A, Minsky B, Rusch V, Turnbull A, Korst R, Ginsberg R, Kelsen DP, Ilson DH. A phase II trial of preoperative combined-modality therapy for localized esophageal carcinoma: initial results. J Thorac Cardiovasc Surg. 2002 Aug;124(2):27 — View Citation

Enzinger E, Ilson D, Minsky B, et al.: Phase I/II neoadjuvant concurrent 96 hour taxol, cisplatin, and radiation therapy: promising toxicity profile and response in localized esophageal cancer. [Abstract] Proceedings of the American Society of Clinical On