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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Procedure: Surgery; Radiation: Prophylactic Cranial Irradiation; Drug: Cisplatin; Radiation: Chest Irradiation; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT00984997

ID92-038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Surgery + Radiotherapy + Chemotherapy

Experimental group

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.

Treatment:

Drug: Etoposide

Radiation: Chest Irradiation

Procedure: Surgery

Radiation: Prophylactic Cranial Irradiation

Drug: Cisplatin