Clinical trial · Interventional

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

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

NCT00984997CI-TRIAL-00022792completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Chest Irradiation	Radiation	—	UNRESOLVED
Cisplatin	Drug	Cisplatin	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Prophylactic Cranial Irradiation	Radiation	—	UNRESOLVED
Surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Surgery + Radiotherapy + Chemotherapy
description
Surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. 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. Cisplatin 50 mg/M\^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29. 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. 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.
interventionNames
1. Procedure: Surgery
2. Radiation: Chest Irradiation
3. Drug: Cisplatin
4. Drug: Etoposide
5. Radiation: Prophylactic Cranial Irradiation

Primary outcomes (1)

measure
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
timeFrame
Assessed from one month after completion of chemotherapy to year 10

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. No previous treatment.
2. Tumor must be resectable.
3. \>/= 18 and \</= 70 years of age.
4. Zubrod performance status \</= or higher performance status if based only on pain.
5. Must have adequate bone marrow, liver and renal function as defined in 3.6.

Exclusion Criteria:

1. Cytological or histological proof of N3 disease.
2. Evidence of metastatic disease to distant sites.
3. Patients with impending cord compression will be ineligible.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Oct 1, 1993
Primary completion: Jun 1, 2007
Completion: Jun 1, 2015
First posted: Sep 25, 2009
Last update posted: Jun 30, 2016
Enrollment: 38 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Keywords: Superior Sulcus Tumor, Lung Cancer, Non-Small Cell, Multimodality Treatment, Surgery, Segmentectomy, Lobectomy, Cisplatin, CDDP, Etoposide, VP-16, VePesid, Radiation Therapy, Radiotherapy, Chest Irradiation, Prophylactic Cranial Irradiation, PCI

Data updated 22 days agoSource updated Jun 30, 2016source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.