Phase II trial of SPM-011 + BNCT30 for unresectable locally recurrent HNSCC or unresectable HNNSCC

Phase II trial of the combination of SPM-011 and BNCT System (BNCT30) for unresectable locally recurrent HNSCC or unresectable HNNSCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224571

Enrollment

Registered

2019-02-22

Start date

2016-06-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Interventions

investigational material(s) Generic name etc : BNCT30 (investigational device) INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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)

Exclusion criteria

Exclusion criteria: (1) Active multiple primary cancers (2) Distant metastasis (3) Active infections requiring systemic treatment (4) Serious Complications

Design outcomes

Primary

Measure	Time frame
safety efficacy 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

Measure	Time frame
safety efficacy [Efficacy]Duration of response, disease control rate, complete response rate, comprehensive evaluation, overall survival [Safety]Adverse event, clinical examination	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026