NCT00062439
S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
PHASE2
COMPLETED
NCT00062439
INTERVENTIONAL
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)
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.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Any of the following stages due to involvement of the superior sulcus:
* Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)
* Newly diagnosed
* Primary bronchogenic
* Must meet 1 of the following tumor involvement criteria:
* An apical tumor associated with the Pancoast syndrome (arm or shoulder pain and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the inferior trunk of the bronchial plexus with or without Horner's syndrome) without rib or vertebral body involvement
* Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1 and 2 by CT scan or MRI, with or without an associated Pancoast syndrome
* Superior sulcus tumors with invasion of the vertebral bodies or involvement of the subclavian vessels (T4) by CT scan or MRI, with or without an associated Pancoast syndrome
* No more than 1 parenchymal lesion in the same lung or in both lungs
* No involvement of the following lymph node groups as determined by mediastinal exploration\* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:
* Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or transbronchial Wang needle biopsy, regardless of whether enlarged nodes are visible or not on chest x-ray or CT scan
* Supraclavicular (scalene) nodes
* Any nodes evident on physical exam must be biopsied by fine needle aspiration or open biopsy
* Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy (presumes N2 nodes in the A-P window) NOTE: \*Mediastinal exploration is not required for patients whose mediastinum is negative by both positron-emission tomography (PET) and CT scan
* No pleural effusions except if 1 of the following criteria are met:
* Pleural effusion present before mediastinoscopy or thoracotomy with negative cytology on 2 separate thoracenteses
* Pleural effusion present only after exploratory or staging thoracotomy, with negative cytology on a single thoracentesis
* Present only on CT scan and too small to tap
* No pericardial effusions or superior vena cava syndrome
* No brain metastases by CT scan or MRI
* No evidence of distant metastatic disease by bone scan or PET
* Must be a candidate for potential future pulmonary resection
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-2
* Patients with Zubrod performance status 2 must have an albumin level at least 0.85 times lower limit of normal and weight loss no greater than 10%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*
* SGOT or SGPT no greater than 1.5 times ULN\* NOTE: \*Unless due to a documented benign disease
Renal
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No myocardial infarction within the past 3 months
* No active angina
* No unstable heart rhythms
* No clinically evident congestive heart failure
Pulmonary
* Preresection FEV_1 at least 2.0 L OR
* Predicted postresection FEV_1 greater than 1.0 L
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled peptic ulcer disease
* No grade 2 or greater sensory neuropathy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of consolidation therapy
Chemotherapy
* No prior chemotherapy for lung cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the neck or thorax
* No concurrent intensity-modulated radiotherapy
Surgery
* Prior exploratory thoracotomy allowed only for diagnosis or staging purposes
Other
* No concurrent amifostine
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description: During induction:50 mg/m2,IV on Days 1, 8, 29 \& 36. In any appropriate vehicle over 60 minutes
- Arm Group Labels: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
-
- Type: DRUG
- Name: docetaxel
- Description: During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
- Arm Group Labels: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
-
- Type: DRUG
- Name: etoposide
- Description: During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
- Arm Group Labels: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
-
- Type: PROCEDURE
- Name: conventional surgery
- Description: 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.
- Arm Group Labels: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
-
- Type: RADIATION
- Name: radiation therapy
- Description: 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.
- Arm Group Labels: Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel
- SWOG Cancer Research Network