+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial



Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial



International Journal of Clinical Oncology 15(6): 583-587



The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m(2) on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 054966179

Download citation: RISBibTeXText

PMID: 20714770

DOI: 10.1007/s10147-010-0118-x


Related references

A randomized phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer. Anticancer Research 30(11): 4695-4699, 2011

1190Pa Randomized Phase Ii Trial Of Cisplatin Plus Gemcitabine Versus Carboplatin Plus Gemcitabine In Patients With Completely Resected Non-Small Cell Lung Cancer: Hokkaido Lung Cancer Clinical Study Group Trial (Hot0703). Annals of Oncology 25(Suppl_4): iv414-iv415, 2014

Phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel in patients with completely resected non-small cell lung cancer. Anticancer Research 30(7): 3039-3044, 2010

Phase II trial of postoperative adjuvant cisplatin and etoposide in patients with completely resected stage I-IIIa small cell lung cancer: the Japan Clinical Oncology Lung Cancer Study Group Trial (JCOG9101). Journal of Thoracic and Cardiovascular Surgery 129(5): 977-983, 2005

A randomized phase III trial of adjuvant chemotherapy with UFT for completely resected pathological stage I non-small-cell lung cancer: the West Japan Study Group for Lung Cancer Surgery (WJSG)--the 4th study. Annals of Oncology 16(1): 75-80, 2004

A randomized phase III trial of adjuvant chemotherapy with cisplatin and vindesine followed by UFT for completely resected pathologic (p-) stage IIIA-N2 non-small cell lung cancer (NSCLC): West Japan Study Group for Lung Cancer Surgery (WJSG) - the 5 th Study. Journal of Clinical Oncology 23(16_Suppl): 7262-7262, 2016

A phase II trial of adjuvant chemotherapy with weekly paclitaxel (Pac) and carboplatin (Cb) followed by UFT for completely resected pathologic (p-) stage II (N1) and IIIA (N2) non-small cell lung cancer (NSCLC). Journal of Clinical Oncology 23(16_Suppl): 7315-7315, 2016

A randomized Phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patients with completely resected stage IB or II Non-Small-Cell Lung Cancer. Lung Cancer 90(3): 397-404, 2016

Phase I/II trial of TS-1 plus carboplatin in patients with advanced non-small cell lung cancer: Final report of a Central Japan Lung Study Group Trial-CJLSG0402. Journal of Clinical Oncology 26(15_Suppl): 19056-19056, 2016

Feasibility of adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 for completely resected non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 1001. International Journal of Clinical Oncology 22(2): 274-282, 2016

Multidrug resistance proteins do not predict benefit of adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: International Adjuvant Lung Cancer Trial Biologic Program. Clinical Cancer Research 13(13): 3892-3898, 2007

RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. Journal of Thoracic Oncology 4(1): 80-86, 2009

Phase I trial of TS-1 plus carboplatin in patients with advanced non-small cell lung cancer: A Central Japan Lung Study Group Trial-CJLSG0402. Journal of Clinical Oncology 24(18_Suppl): 17065-17065, 2016

Adjuvant chemotherapy with cyclophosphamide, doxorubicin, and cisplatin in patients with completely resected stage I non-small-cell lung cancer. The Lung Cancer Study Group. Journal of the National Cancer Institute 85(4): 299-306, 1993

A randomized trial comparing adjuvant chemotherapy with gemcitabine plus cisplatin with docetaxel plus cisplatin in patients with completely resected non-small-cell lung cancer with quality of life as the primary objective. Interactive Cardiovascular and Thoracic Surgery 20(6): 783-790, 2016