S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
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|ClinicalTrials.gov Identifier: NCT00062439|
Recruitment Status : Completed
First Posted : June 6, 2003
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: docetaxel Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|Experimental: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel||
During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
Procedure: conventional surgery
If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.
Radiation: radiation therapy
Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.
- 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.
- Adverse Events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Response [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062439
Show 154 Study Locations
|Study Chair:||Michael J. Kraut, MD||Providence Hospital|
|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|