SWOG clinical trial number
S0220

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)

Closed
Phase
Accrual
92%
Published
Abbreviated Title
Cis/VP-16/RT/Surgery/Doc/Selected IIB, Stage IIIA or IIIB (Pancoast Tumors)
Activated
07/01/2003
Closed
10/01/2007
Participants
NCORP, Members, Medical Oncologists, ECOG, NCCTG, ACOSOG, CALGB, NCIC-CTG

Research committees

Lung Cancer

Treatment

Cisplatin Docetaxel VP-16 Radiation Therapy Surgery RT

Eligibility Criteria Expand/Collapse

Pts must have histologic/cytologically-confirmed newly diagnosed, single primary bronchogenic NSCLC, selected Stage IIB, Stage IIIA or IIIB due to involvement of superior sulcus (T3-4, N0-1); EKG obtained; evidence of disease by chest X-ray (PA and lateral views), chest CT (preferable w/contrast) w/bone windows, CT scan of upper abdomen or PET scan (not necessary if chest CT incl. liver and adrenals) and biopsy or aspiration of any suspicious CT/MRI findings; Pleural effusion negative per Section 5.18; Pre-resection FEV1 >/= 2.0 L or if FEV1 < 2.0, predicted post-resection FEV1 > 1.0 L; Zubrod PS 0-2 (PS 2 must have albumin >/= 0.85 x ILLN, Weight Loss </= 10%); ANC >/= 1,500 and PLTS >/= 100,000; adequate hepatic function, total bili and SGOT or SGPT </= 1.5 x IULN (unless benign disese present); CrCl >/= 50 ml/min; Pts must have mediastinal exploration w/lymph nodes biopsied except if mediastinum is negative by both PET and CT; Attending surgeon, medical oncologist and radiation oncologist must approve the staging designation prior to registration; Pts must not have had prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical ca and must be disease-free for 5 yrs; Pts must be a candidate for future pulmonary resection; Pts must not have mediastinal or supraclavicular nodal involvement (N2-3); Pts must not have 2 or more parenchymal lesions in the same or both lungs; Pts must not have malignant pericardial effusions or SVC syndrome; Pts must not have had prior chemo or radiation to the thorax, head or neck region (thoracotomy for staging purposes only); Pts must not have evidence of distant mets via bone scan or PET scan; Pts must not have unstable cardiac rhythms, uncontrolled CHF, PUD, active angina or recent MI; Pt must not have brain mets via CT or MRI of the brain; Pts must not have > Grade 1 neuropathy-sensory; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; Pts must be offered participation in S9925 (the Lung Cancer Specimen Repository); Pts must not have hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

Publication Information Expand/Collapse

2014

Trimodality therapy for superior sulcus non-small cell lung cancer: Southwest Oncology Group-Intergroup trial S0220

K Kernstine;J Moon;M Kraut;K Pisters;J Sonett;V Rusch;C Thomas;T Waddell;J Jett;A Lyss;S Keller;D Gandara Annals of Thoracic Surgery 98(2):402-410;

PMid: PMID24980603 | PMC number: PMC4122593

2013

Induction chemoradiotherapy followed by consolidation cytotoxic therapy for superior sulcus (Pancoast tumors) non-small cell lung cancer: a SWOG-coordinated feasibility phase II intergroup trial (S0220)

K Kernstine;J Moon;M Kraut;K Pisters;J Sonett;V Rusch;CR Thomas;T Waddell;J Jett;A Lyss;S Keller;D Gandara Annals of Thoracic Surgery 94(6):2172-2175; Society of Thoracic Surgeons 2013 Annual Meeting (Jan 26-30, 2013, Los Angeles, CA), oral presenation;

2009

Docetaxel is not feasible as consolidation therapy after cisplatin/etoposide/concurrent radiotherapy followed by surgical resection for pancoast tumors: preliminary results of SWOG 0220

MJ Kraut;J Moon;CR Thomas;J Sonett;J Jett;V Rusch;AP Lyss;H Gillenwater;S Laurie;D Gandara Journal of Thoracic Oncology 4(9)suppl 1, abst. PD8.2.6,S522, 2009 (IASLC 13th World Conf on Lung Cancer, poster)

2008

Cooperative group research efforts in lung cancer: focus on early stage non-small cell lung cancer

H Wakelee;C Langer;E Vokes;J Schiller;P Bass;N Saijo;A Adjei;F Shepherd;H Choy;DR Gandara Clinical Lung Cancer 9(1):9-15

PMid: PMID18282352 | PMC number: (Reviews are not within the scope of the Public Access )

2005

Therapeutic strategies for combined-modality therapy of locally advanced non-small cell lung cancer: rationale for consolidation docetaxel therapy

DR Gandara;E Vallieres;LE Gaspar;K Kelly;KS Albain;RS Herbst Jr;PN Lara Jr;P Mack;PH Gumerlock;JJ Crowley Clinical Lung Cancer 7 Suppl 3:S93-97