At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed non-small cell lung cancer
- ✓Stage IIB, IIIA, or IIIB disease due to superior sulcus involvement
- ✓Newly diagnosed, primary bronchogenic tumor
- ✓Apical tumor with Pancoast syndrome and no rib/vertebral involvement, OR superior sulcus tumor with chest wall involvement (T3), OR superior sulcus tumor with vertebral body invasion or subclavian vessel involvement (T4)
- ✕Pleural effusion except if negative cytology on thoracenteses or too small to tap
- ✕Pericardial effusions or superior vena cava syndrome
- ✕Brain metastases by CT or MRI
- ✕Distant metastatic disease by bone scan or PET
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating cisplatin, docetaxel, and 3 other interventions for Lung Cancer. Completed, enrolled 46 participants across 154 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.