Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2003 Sep 1;89(5):803-7.
doi: 10.1038/sj.bjc.6601227.

Phase I/II study of daily carboplatin, 5-fluorouracil and concurrent radiation therapy for locally advanced non-small-cell lung cancer

H Yoshizawa  1 , J Tanaka, H Kagamu, Y Maruyama, H Miyao, K Ito, T Sato, A Iwashima, E Suzuki, F Gejyo
Affiliations
Clinical Trial

Phase I/II study of daily carboplatin, 5-fluorouracil and concurrent radiation therapy for locally advanced non-small-cell lung cancer

H Yoshizawa et al. Br J Cancer. .

Abstract

A study was undertaken to determine the maximum tolerated dose, the dose-limiting toxicities and the response rate of carboplatin and 5-fluorouracil administered daily with concurrent thoracic radiation therapy in patients with locally advanced non-small-cell lung cancer. In a phase I/II clinical trial, patients with histologically documented, unresectable stage IIIA or IIIB non-small-cell lung cancer (NSCLC) were enrolled. Carboplatin (20-40 mg m(-2) 2-h infusion, daily) and 5-fluorouracil (200 mg m(-2) 24-h continuous infusion, daily) were administered concurrently with radiotherapy on days 1-33. Radiotherapy, with a total dose of 60 Gy, was delivered in 30 fractions on days 1-40. In the phase I portion, the daily dose of carboplatin was escalated from 20 to 40 mg m(-2). Once the maximum tolerated dose (MTD) and recommended dose (RD) of carboplatin was determined, the study entered the phase II portion. In the phase I portion, the daily MTD and RD of carboplatin were 40 and 35 mg m(-2), respectively. The dose-limiting toxicity was neutropenia. In the following phase II study, 30 patients were entered and the objective response rate was 76.7% (95% CI, 62-92%) and the local control rate was 85.7%. The median survival time was 19.8 months, with a survival rate of 70% at 1 year, 36.7% at 2 years. The major toxicities of treatment were neutropenia (>or=grade 3, 87.9%) and thrombocytopenia (>or=grade 3, 23.3%). This combined therapy for locally advanced non-small-cell lung cancer is promising and shows acceptable toxicity.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Treatment schema for daily carboplatin, 5-FU and concurrent radiation therapy.
Figure 2
Figure 2
Survival rate–the 1-year survival rate was 70%.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Arriagada R, Le Chevalier T, Quoix E, Ruffie P, de Cremoux H, Douillard JY, Tarayre M, Pignon JP, Laplanche A (1991) ASTRO (American Society for Therapeutic Radiology and Oncology) plenary: effect of chemotherapy on locally advanced non-small-cell lung carcinoma: a randomized study of 353 patients. GETCB (Groupe d'Etude et Traitement des Cancers Bronchiques), FNCLCC (Federation Nationale des Centres de Lutte contre le Cancer) and the CEBI trialists. Int J Radiat Oncol Biol Phys 20: 1183–1190 - PubMed
    1. Begg AC, van der Kolk PJ, Emondt J, Bartelink H (1987) Radiosensitization in vitro by cis-diammine (1,1-cyclobutanedicarboxylato) platinum(II) (carboplatin, JM8) and ethylenediammine-malonatoplatinum(II) (JM40). Radiother Oncol 9: 157–165 - PubMed
    1. Belani CP, Aisner J (1994) Combined chemotherapy and radiation in locally advanced non-small cell lung cancer. Semin Oncol 21: 79–90 - PubMed
    1. Belani CP, Aisner J, Bahri S, Jett J, Day R, Capazolli MJ, Hiponia D, Engstrom C (1996) Chemoradiotherapy in non-small cell lung cancer: paclitaxel/carboplatin/radiotherapy in regionally advanced disease. Semin Oncol 23: 113–116 - PubMed
    1. Blackstock AW, Lesser GJ, Fletcher-Steede J, Case LD, Tucker RW, Russo SM, White DR, Miller A (2001) Phase I study of twice-weekly gemcitabine and concurrent thoracic radiation for patients with locally advanced non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 51: 1281–1289 - PubMed

Publication types

MeSH terms