S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
- Conditions
- Lung Cancer
- Interventions
- Procedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00062439
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the feasibility 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.
OUTLINE:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel cisplatin - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel docetaxel - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel etoposide - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel conventional surgery - Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel radiation therapy -
- Primary Outcome Measures
Name Time Method Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel. After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.
- Secondary Outcome Measures
Name Time Method Response After completion of induction therapy. Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.
Adverse Events Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Overall Survival daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Progression-Free Survival at 3 Years At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Trial Locations
- Locations (153)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Scroll for more (143 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States