Phase II trial of SPM-011 + BNCT30 for unresectable locally recurrent HNSCC or unresectable HNNSCC
- Conditions
- unresectable locally recurrent squamous cell carcinoma of the head and neck(HNSCC) or unresectable non-squamous cell carcinoma of the head and neck(HNNSCC)
- Registration Number
- JPRN-jRCT2080224571
- Lead Sponsor
- Sumitomo Heavy Industries, ltd.
- Brief Summary
In 21 patients with local recurrent head and neck squamous cell carcinoma or head and neck non-squamous cell carcinoma, the response rate of 90 days after BNCT was 71.4% and the complete response rate was 23.8%. The overall survival rate (730 days after BNCT) was 85.2%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 21
(1) Document consent by his/her own free will
(2) 20 years old or older
(3) 60% of Karnofsky Performance Status (KPS) or higher
(4) The primary lesion is histologically head and neck cancer
(5) At least one measureable lesion in the target lesion site based on RECIST (version 1.1)
(6) Prior radiation therapy satisfying one of the following conditions:
(6) Prior radiation therapy satisfying one of the following conditions:
For locally recurrent squamous cell carcinoma:
- Radiation therapy, fractionation around 2Gy/day, total dose within the range of 40 - 75 Gy
For non-squamous cell carcinoma:
- No prior radiation therapy
- Radiation therapy, not more than 75 Gy of total biologically effective dose
(7) 90 days or more have passed since the last irradiation date of prior radiation therapy for the evaluation target lesion site to the scheduled date of BNCT, except for non-squamous cell carcinoma with no history of prior radiation therapy
(8) Over 90 days of survival is expected after BNCT.
(9) Non problematic disorder (Screening test)
(1) Active multiple primary cancers
(2) Distant metastasis
(3) Active infections requiring systemic treatment
(4) Serious Complications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Tumor resuponse (response rate):Tumor response was evaluated within 90 days after BNCT using RECIST (version 1.1). Response rate is defined as the ratio of the number of cases with CR or PR of the evaluated lesions to the number of all eligible cases.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>[Efficacy]Duration of response, disease control rate, complete response rate, comprehensive evaluation, overall survival<br>[Safety]Adverse event, clinical examination