+ 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 radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma LAUCC Kitasato Gynecologic Radiation Oncology Group KGROG 0501 - initial analysis



Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma LAUCC Kitasato Gynecologic Radiation Oncology Group KGROG 0501 - initial analysis



European Journal of Gynaecological Oncology 29(3): 222-224



Objective: Locally advanced uterine cervical carcinoma (LAUCC) treated with chemoradiotherapy is considered to be the standard treatment regimen. However, no evidence of its efficacy and safety has been obtained from the Japanese population. Furthermore. the total dose of Japanese radiation therapy protocol is less than that of the USA which indicated that chemoradiotherapy for LAUCC is better than radiation therapy alone by phase III clinical trials. Thus, the current phase II study was designed to evaluate chemoradiotherapy with a lower radiation dose for LAUCC using weekly nedaplatin effectively and safely in the Japanese population. Nedaplatin is a platinum drug and no hydration is required to infuse patients because it is less toxic on renal function. If this phase II trial is successful, chemoradiotherapy for LAUCC in out-patient clinics could be possible. Patients and Methods: Patients registered in the current study were found to have LAUCC based on the following criteria i) pathologically proven squamous cell carcinoma or adenocarcinoma, ii) FIGO clinical Stage Ib, IIa, IIb with bulky tumor (diameter > 40 mm assessed by pelvic magnetic resonance imaging) or pelvic lymph node swelling (diameter > 10 mm assessed by pelvic computed tomography); iii) FIGO clinical Stage IIIa, IIIb and IVa with no paraaortic lymph node swelling (diameter > 10 mm) observed by abdominal computed tomography; iv) age: 20-75 years; v) performance status: 0-2. The treatment protocol was as follows: Radiation therapy in a combination of external beam radiation therapy (total dose: 50 Gy-52 Gy/25-27 fractions with central shielding after 30-32 Gy) with high-dose rate intracavitary irradiation (24-30 Gy/4-6 fractions to point A). Chemotherapy applied in the current study was weekly nedaplatin infused intravenously (30 mg/mm(2)/time, once a week, total 150 mg/mm(2)/5 weeks). Sample size in the current study was 45 LAUCC patients recruited for three years at a single institution. This protocol was permitted by the ethics committee of Kitasato University Hospital. Results: Ten patients were registered in this study between June 2005 and March 2006. The median age was 57.5 years (range 36-73). PS0 was five and PS1 was five. As for clinical stage, nine were IIIb and only one was IIb. Nine patients were proven to have squamous cell carcinoma and one adenocarcinoma. The median maximum tumor diameter was 62.5 mm (range 30-100 mm). As for initial response, eight had CR and two had PR (100% response rate). As for hematological acute morbidity, three were grade 2, six were grade 3, and one was grade 4. Conclusions: This initial analysis of the phase II study confirmed that concurrent chemoradiotherapy using nedaplatin is safe and efficacious, thus we decided to undergo further studies.

Please choose payment method:






(PDF emailed within 1 workday: $29.90)

Accession: 032786908

Download citation: RISBibTeXText

PMID: 18592783


Related references

Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501). Japanese Journal of Clinical Oncology 37(1): 70-72, 2007

A phase II trial of radiation therapy and weekly cisplatin chemotherapy for the treatment of locally-advanced squamous cell carcinoma of the vulva: A gynecologic oncology group study. Yearbook of Oncology 2012: 132-133, 2012

A phase II trial of radiation therapy and weekly cisplatin chemotherapy for the treatment of locally-advanced squamous cell carcinoma of the vulva: a gynecologic oncology group study. Gynecologic Oncology 124(3): 529-533, 2012

A phase I study of concurrent weekly topotecan and cisplatin chemotherapy with whole pelvic radiation therapy in locally advanced cervical cancer: a gynecologic oncology group study. Gynecologic Oncology 125(1): 158-162, 2012

Hyperfractionated radiation therapy plus chemotherapy in locally advanced cervical cancer: results of two phase I dose-escalation Gynecologic Oncology Group trials. Gynecologic Oncology 75(3): 349-355, 1999

A phase I study of gemcitabine followed by cisplatin concurrent with whole pelvic radiation therapy in locally advanced cervical cancer: a Gynecologic Oncology Group study. Gynecologic Oncology 107(2): 274-279, 2007

A phase II multicenter trial of concurrent chemoradiotherapy with weekly nedaplatin in advanced uterine cervical carcinoma: Tohoku Gynecologic Cancer Unit Study. Oncology Reports 19(6): 1551-1556, 2008

Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10). International Journal of Radiation Oncology Biology Physics 63(3): 788-794, 2005

Radiation therapy with or without weekly cisplatin for bulky stage 1B cervical carcinoma: follow-up of a Gynecologic Oncology Group trial. American Journal of Obstetrics and Gynecology 197(5): 503.E1, 2007

Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung. International Journal of Radiation Oncology, Biology, Physics 84(2): 456-463, 2012

Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522. International Journal of Radiation Oncology Biology Physics 97(4): 687-699, 2017

Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma: a randomized comparative trial of the Radiation Therapy Oncology Group. Urology 45(4): 616-623, 1995

NRG Oncology Radiation Therapy Oncology Group 0822: A Phase 2 Study of Preoperative Chemoradiation Therapy Using Intensity Modulated Radiation Therapy in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer. International Journal of Radiation Oncology Biology Physics 93(1): 29-36, 2015

Comparative quality-adjusted survival analysis between radiation therapy alone and radiation with androgen deprivation therapy in patients with locally advanced prostate cancer: a secondary analysis of Radiation Therapy Oncology Group 85-31 with novel decision analysis methods. Prostate International 6(4): 140-144, 2018

Insufficiency fractures after pelvic radiation therapy for uterine cervical cancer: an analysis of subjects in a prospective multi-institutional trial, and cooperative study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG). International Journal of Radiation Oncology, Biology, Physics 84(2): E195-E200, 2012