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Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Surgery (Procedure); Chest Irradiation (Radiation); Cisplatin (Drug); Etoposide (Drug); Prophylactic Cranial Irradiation (Radiation)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Ritsuko Komaki, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Summary

1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy. 2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

Clinical Details

Official title: Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Outcomes Following Surgery and Accelerated Radiation Therapy/Chemotherapy

Detailed description: Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy. Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29. If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. No previous treatment. 2. Tumor must be resectable. 3. >/= 18 and

Locations and Contacts

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: October 1993
Last updated: October 9, 2014

Page last updated: August 23, 2015

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