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

Closed
Phase
Accrual
74%
Published
Abbreviated Title
Cis/VP-16/RT/Consol. Doc followed by ZD1839/Placebo /IIIA & selected IIIB NSCLC
Activated
06/15/2001
Closed
04/15/2005
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, EPP, CTSU

Research committees

Lung Cancer

Treatment

Cisplatin Docetaxel Etoposide Radiation Therapy ZD1839

Eligibility Criteria Expand/Collapse

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.

Publication Information Expand/Collapse

2019

Toxicity Related to Radiotherapy Dose and Targeting Strategy: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Locally Advanced Non-Small Cell Lung Cancer

S Schild;W Fan;T Stinchcombe;E Vokes;S Ramalingam;J Bradley;K Kelly;H Pang;X Wang Journal of Thoracic Oncology Feb;14(2):298-303

PMid: PMID30292852 | PMC number: PMC6348032

Clinical prognostic model for older patients with advanced non-small cell lung cancer

AK Ganti;X Wang;T Stinchcombe;Y Wang;J Bradley;HJ Cohen;K Kelly;R Paulus;SS Ramalingam;EE Vokes;H Pang Journal of Geriatric Oncology Feb 20. pii: S1879-4068(18)30197-8. doi: 10.1016/j.jgo.2019.02.007. [Epub ahead of print]

PMid: PMID30797707

2018

Exploring Radiotherapy Targeting Strategy and Dose: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Stage III NSCLC

SE Schild;HH Pang;W Fan;T Stinchcombe;EE Vokes;SS Ramalingam;J Bradley;K Kelly;X Wang Journal of Thoracic Oncology Aug;13(8):1171-1182

PMid: PMID29689435

2017

History of diabetes and outcome among participants 65 or older in SWOG clinical trials

DL Hershman;C Till;JD Wright;S Ramsey;W Barlow;J Unger JCO Clinical Cancer Informatics Nov;1:1-12; DOI: https://doi.org/10.1200/CCI.17.00040 Publishedonlineonascopubs.org/journal/ccion November 20, 2017.

PMid: PMID30657402

A pooled analysis of individual patient data of concurrent chemoradiotherapy for stage 3 non-small-cell lung cancer in elderly patients compared to younger patients who participated in United States National Cancer Institute Cooperative Group studies

T Stinchcombe;Y Zhang;E Vokes;J Schiller;J Bradley;K Kelly;W Curran;SE Schild;B Movsas;G Clamon;R Govindan;G Blumenschein;M Socinski;N Ready;WL Akerley;HJ Cohen;H Pang;X Wang Journal of Clinical Oncology Sep 1;35(25):2885-2892

PMid: PMID28493811 | PMC number: PMC5578390

2016

Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials

D Hershman;C Till;J Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology Sep 1;34(25):3014-3022; 2016 Jun 20 [Epub ahead of print]

PMid: PMID27325863 | PMC number: PMC5012713

Comorbidities and risk of chemotherapy induced peripheral neuropathy among participants in SWOG clinical trials

DL Hershman;C Till;JD Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology 34, 2016 (suppl; abstr 10001); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral presentation

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

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-8241

Treatment of Advanced Non-Small Cell Lung Cancer: PVp Versus PVpM Versus PVe Versus PVeMI Versus FOMi/CAP

Research Committee(s)
Lung Cancer
Activated
12/23/1982
Closed
11/01/1984
Closed
Phase
III
Published