Clinical trial NCT00062439
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
Sponsor: SWOG Cancer Research Network
Start date: 2003-07-01; Completion date: 2010-12-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: None
Interventions: intervention 1: cisplatin intervention 2: docetaxel intervention 3: etoposide intervention 4: conventional surgery intervention 5: radiation therapy
Intervention descriptions: intervention 1: During induction:50 mg/m2,IV on Days 1, 8, 29 \& 36. In any appropriate vehicle over 60 minutes intervention 2: During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes intervention 3: During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes. intervention 4: 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. intervention 5: 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.

Protocol documents: