Lung Cancer
Conditions
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
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.
Interventions
PROCEDURESurgery
Segmentectomy or lobectomy with en bloc resection of the involved chest.
RADIATIONChest 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.
DRUGCisplatin
50 mg/M\^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
DRUGEtoposide
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.
RADIATIONProphylactic 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
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy | Assessed from one month after completion of chemotherapy to year 10 | 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. |
Countries
United States
Outcome results
None listed