Send to

Choose Destination
See comment in PubMed Commons below
Am J Clin Oncol. 2011 Apr;34(2):115-9. doi: 10.1097/COC.0b013e3181c4c7a8.

Phase II study of radiation therapy combined with weekly low-dose gemcitabine for locally advanced, unresectable pancreatic cancer.

Author information

Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan.



Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer.


The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study.


In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m.


Between December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized.


Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.

[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Lippincott Williams & Wilkins
    Loading ...
    Support Center