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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery + Radiotherapy + Chemotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Segmentectomy or lobectomy with en bloc resection of the involved chest. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ritsuko Komaki, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010178 | Pancoast Syndrome |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| Chest Irradiation | 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 | Drug | 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29. |
|
|
| Etoposide | 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 | 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. |
|
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017671 |
| Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |