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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003087
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: paclitaxel
Procedure: surgical procedure
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 25
Study Start Date: August 1997
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Detailed 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003087

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David H. Ilson, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
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 Oncology 18: A1038, 1999.

ClinicalTrials.gov Identifier: NCT00003087     History of Changes
Other Study ID Numbers: 97-088, CDR0000065787, NCI-T97-0066
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage II esophageal cancer
stage III esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014