Determining the recommended dose of stereotactic body radiotherapy boost in patients with cervical cancer who are unsuitable for intracavitary brachytherapy: a phase I dose-escalation study
| Autor: | Kei Ito, Satoshi Kito, Keiji Nihei, Nao Kino, Hiroaki Ogawa, Toshiharu Yasugi, T. Shimizuguchi, Hiroshi Tanaka, Katsuyuki Karasawa, Yujiro Nakajima |
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| Rok vydání: | 2019 |
| Předmět: |
Cancer Research
medicine.medical_specialty medicine.medical_treatment Brachytherapy Uterine Cervical Neoplasms Phases of clinical research Radiosurgery 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Intracavitary Radiation Therapy medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Adverse effect Aged Cervical cancer business.industry Radiotherapy Dosage General Medicine Middle Aged medicine.disease Radiation therapy Clinical trial Oncology 030220 oncology & carcinogenesis Female Radiology business Stereotactic body radiotherapy |
| Zdroj: | Japanese Journal of Clinical Oncology. 49:856-861 |
| ISSN: | 1465-3621 |
| DOI: | 10.1093/jjco/hyz074 |
| Popis: | Objective Some patients are ineligible for intracavitary brachytherapy (ICBT) for locally advanced cervical cancer. Stereotactic body radiotherapy (SBRT) could be a good treatment option for such patients. This phase I clinical trial aimed to determine the recommended SBRT boost dose for ICBT-ineligible cervical cancer patients. Methods Patients with untreated uterine cervical cancer (clinical stages IB1-IIIB) who were ineligible for ICBT were enrolled. Radiotherapy consisted of whole-pelvis radiotherapy (45 Gy in 25 fractions) followed by SBRT. Three dose levels of SBRT (19.5/21/22.5 Gy in three fractions) were set; the treatment protocol began at 21 Gy (level 2). The 'rolling-six' design study was used to establish the recommended dose of SBRT. Each dose level covered three or six patients. The primary endpoint included dose-limiting toxicity (DLT), defined as the occurrence of grade 3 (or worse) non-hematologic adverse effects within 6 months after SBRT. Results The median follow-up after registration was 17 (range, 8-32) months. Three patients were enrolled in study level 2 (SBRT of 21 Gy); none of the patients exhibited DLT within 6 months after treatment completion. In study level 3 (SBRT of 22.5 Gy), three patients did not exhibit DLT. Although all six patients achieved locoregional control during follow-up, one patient treated with level 2 SBRT experienced distant metastases 14 months after registration. Conclusions The recommended dose of SBRT boost was 22.5 Gy in three fractions. We plan to conduct a phase II multi-center clinical trial using the methodology obtained from the current study. |
| Databáze: | OpenAIRE |
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