Phase 2 N=46 Treatment

S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00062439 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Nov 2013

Primary outcome: Primary: 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. — 45 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cisplatin (Drug); docetaxel (Drug); etoposide (Drug); conventional surgery (Procedure); radiation therapy (Radiation)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	45	—
SECONDARY Adverse Events	0; 3; 0; 1; 0; 0	—
SECONDARY Overall Survival	4	—
SECONDARY Progression-Free Survival at 3 Years	56	—
SECONDARY Response	28	—

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.

Eligibility Criteria

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 explorat

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Data sourced from ClinicalTrials.gov (NCT00062439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.