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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984997
• Other study ID #: ID92-038
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: June 29, 2016
• Start date: October 1993
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2015
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy	Locoregional control (LRC) defined as disease non-recurrence in a localized area for patients with resectable superior sulcus tumors treated with surgical resection followed by adjuvant chemoradiation. LRC measured as percentage of participants without recurrence at rates of local control as measured Years 2, 5, and 10.	Assessed from one month after completion of chemotherapy to year 10	No

External Links

•   University of Texas MD Anderson Cancer Center Website