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

NCT ID: NCT00984997

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-10-31
• Study Completion Date: 2015-06-30

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery + Radiotherapy + Chemotherapy

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.

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

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

Chest Irradiation

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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

Intervention Type: RADIATION

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.

Interventions

Surgery

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

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

Cisplatin

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

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

Radiotherapy; Platinol; CDDP; VePesid; VP-16; PCI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ritsuko Komaki, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

ID92-038

Identifier Type: -

Identifier Source: org_study_id