SWOG clinical trial number
JBR10

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation

Closed
Phase
Published
Abbreviated Title
Chemo/Surgery/Path/QOL in NSCLC
Activated
12/01/1996
Closed
04/30/2001
Participants
NCORP, Members, Medical Oncologists, Surgeons, Pathologists

Research committees

Lung Cancer

Treatment

Cisplatin Vinorelbine tartrate

Eligibility Criteria Expand/Collapse

Histologic proof of primary non-small cell lung cancer ; pts. must be classified pre-operatively as Stage II (T2 N0 M0, T1 N1 M0, T2 N1 M0); pts. with T3 tumors are not eligible for this study; pre-op CT scan of chest; a complete mediastinal lymph node resection or sampling should be attempted; a mediastinal lymph node >1.5 cm on CT must be biopsied and found histologically negative; tumour must be surgically resected by lobectomy, sleeve resection, bilobectomy, or pnuemonectomy, with negative margins; representative paraffin block must be submitted within 2 months of randomization; pts. with bronchioloalveolar carcinoma of lobar or multi-lobar involvement are not eligible; a combination of small-cell and non-small cell carcinomas is not allowed; pts. with more than one discrete area of apparent primary cancer are ineligible; pts. with disease at nodal station #10 (tracheo-bronchial angle) are ineligible; no CHF or uncontrolled infection.

Publication Information Expand/Collapse

2010

Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10 [PMID19922915; PMC2799232]

CA Butts;K Ding;L Seymour;P Twumasi-Ankrah;B Graham;D Gandara;DH Johnson;KA Kesler;M Green;M Vincent;Y Cormier;G Goss;B Findlay;DH Johnson;MS Tsao;FA Shepherd Journal of Clinical Oncology 289(1):29-34

2005

Vinorelbine plus cisplatin vs observation in resected non-small-cell lung cancer

T Winton;R Livingston;D Johnson;J Rigas;M Johnston;C Butts;Y Cormier;G Goss;R Inculet;E Vallieres;W Fry;D Bethune;J Ayoub;K Ding;K Seymour;B Graham;MS Tsao;D Gandara;K Kesler;T Demmy;F Shepherd New England Journal of Medicine 352(25):2589-2597

2002

Compliance with adjuvant chemotherapy (ACT) in non-small lung cancer (NSCLC): NCIC-CTG BR.10/JBR.10.

N Alam;F Shepherd;T Winton;B Graham;D Johnson;R Livingston;J Rigas;M Whitehead;K Ding;L Seymour Proc of the American Society of Clinical Oncology 22:633(#2547)

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