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

NCT00984997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-06-30

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Surgery

Segmentectomy or lobectomy with en bloc resection of the involved chest.

RADIATION

Chest Irradiation

Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.

DRUG

Cisplatin

50 mg/M\^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.

DRUG

Etoposide

given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.

RADIATION

Prophylactic Cranial Irradiation

25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ritsuko Komaki, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-10-31
Primary Completion
2007-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984997 on ClinicalTrials.gov