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)
Overview
- Phase
- Phase 2
- Intervention
- cisplatin
- Conditions
- Lung Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 46
- Locations
- 153
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
Intervention: cisplatin
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
Intervention: docetaxel
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
Intervention: etoposide
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
Intervention: conventional surgery
Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
Intervention: radiation therapy
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Response(After completion of induction therapy.)
- Adverse Events(Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.)
- Overall Survival(daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.)
- 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.)