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)

Other Clinical Trials

SWOG Clinical Trial Number
S2414

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)

Research Committee(s)
Lung Cancer
Symptom Control and Quality of Life
Activated
03/14/2025
Accrual
2%
Open
Phase
SWOG Clinical Trial Number
CTSU/A082304/S2402