SWOG clinical trial number
S0023
A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetacel followed by Maintenance Therapy with ZD1839 (NSC-715055) or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Abbreviated Title
Cis/VP-16/RT/Consol. Doc followed by ZD1839/Placebo /IIIA & selected IIIB NSCLC
Participants
NCORP,
Members, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, EPP, CTSU
Treatment
Cisplatin
Docetaxel
Etoposide
Radiation Therapy
ZD1839
Pts. must have histologic or cytologic-proven newly diagnosed single, primary unresectable IIIA or IIIB NSCLC. If IIIA (N2): N2-proven by biopsy; + node on FDG-PET: Nodes > 3cm on CT or paralyzed L true vocal cord w/separate primary distinct from AP window nodes on CT. If IIIB: N3-proven biopsy of supraclavicular or contralateral mediastinal nodes; contralateral nodes > 3 cm on CT; node + by FDG-PET; or R primary w/paralyzed L true vocal cord. If T4: Tumor of any size invading mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina; or radiographic soft tissue extension into mediastinal space. Pts. w/brain mets are ineligible. Pts. w/2 or more parenchymal lesions on same or opposite sides of the lung are ineligible. Pts. must not have malignant pleural effusions (except pleural effusions visible only on CT scan and not on CXR or deemed too small to tap), pericardial effusions or positive cervical nodes. Pts. must not have had prior chemo, RT for lung cancer, previous surgical resection except to diagnose stage or uncontrolled DM or cardiac disease. Pts. must have creatinine clearance of >= 50 cc/min., FEV1 >= 2.0 L, or predicted FEV1 of the contralateral lung > 800ml; WBC >= 3,000, ANC >= 1,500 and PLTS >=100,000. Pts. must be offered participation in S9925 -Lung Cancer Specimen Repository.
This study has been approved by NCI's Central Institutional Review Board.
2009
Cooperative group research efforts in thoracic malignancies 2009: a review from the 10th Annual International Lung Cancer Congress [PMID19900856]
H Wakelee;BW Loo;KH Kernstine;JB Putnam;MJ Edelman;EE Vokes;HJ Schiller;P Baas;N Saijo;A Adjei;G Goss;H Choy;DR Gandara Clinical Lung Cancer 10(6):395-404
PMC number: n/a (review)
2008
Maintenance gefitinib or placebo following concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small cell lung cancer: A phase III Southwest Oncology Group study S0023 [PMID18378568]
K Kelly;K Chansky;LE Gaspar;KS Albain;J Jett;YC Ung;DHM Lau;DR Gandara Journal of Clinical Oncology 26(15)2450-2456
Reply to correspondence, JCO/2008/184218, "SWOG S0023: what meets the eye may be only half the truth" [PMID18779597]
K Kelly;M Redman;DR Gandara Journal of Clinical Oncology 26(29)4850-4851
Summary report 7th annual targeted therapies of the treatment of lung cancer [PMID18449013;PMC3374724]
L Einhorn;P Bonomi;P Bunn;ER Camidge;DP Carbone;H Choy;S Dubinett;D Gandara;L Gaspar;R Govindan;DH Johnson;J Minna;G Scagliotti;H West;R Herbst Journal of Thoracic Oncology 3:545-555
2007
Updated analysis of SWOG 0023: a randomized phase III trial of gefitinib versus placebo maintenance after definitive chemoradiation followed by docetaxel in patients with locally advanced stage III non-small cell lung cancer
K Kelly;K Chansky;LE Gaspar;JR Jett;Y Ung;KS Albain;JJ Crowley;DR Gandara Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#7513
2005
Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and gefitinib/placebo maintenance in patients with inoperable stage III non-small cell lung cancer
K Kelly;LE Gaspar;K Chansky;KS Albain;J Crowley;DR Gandara Proc of the ASCO, JCO 23(16S):634s (#7058)
Southwest Oncology Group: Two decades of experience in non-small cell lung cancer
AT Turrisi;J Crowley;K Albain;L Gaspar;D Gandara Seminars in Oncology 32(2Suppl3):S119-S121
PMid: PMID16015548
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
2003
Report from the Radiation Oncology Committee of the Southwest Oncology Group (SWOG): Research Objectives Workshop 2003 PMID14528084
P Okunieff;RE Meyn;BA Teicher;CR Thomas, Jr.;LE Gaspar;D Raben;S Giri;RS Lavey;AT Turrisi;GP Swanson;SR Smalley American Journal of Clinical Oncology 26(5):522-529
PMid: PMID14528084
