S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)|
- Measurability of lesions [ Designated as safety issue: No ]
- Objective status [ Designated as safety issue: No ]
- Response [ Designated as safety issue: No ]
- Performance status [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to death [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- Determine the feasbility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus (Pancoast tumors).
- Determine overall survival of patients treated with this regimen.
- Determine time to progression in patients treated with this regimen.
- Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Induction chemoradiotherapy: Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks.
Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.
- Consolidation chemotherapy: Within 3-8 weeks after thoracotomy, patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Show 154 Study Locations
|Study Chair:||Michael J. Kraut, MD||Providence Cancer Institute at Providence Hospital - Southfield Campus|
|Study Chair:||Tien Hoang, MD||University of Wisconsin, Madison|
|Study Chair:||Valerie W. Rusch, MD, FACS||Memorial Sloan-Kettering Cancer Center|
|Study Chair:||James R. Jett, MD||Mayo Clinic|
|Study Chair:||Scott A. Laurie, MD, FRCPC||Ottawa Regional Cancer Centre|
|Study Chair:||Alan P. Lyss, MD||Missouri Baptist Cancer Center|