A Phase I/II clinical trial of Carbon-ion radiotherapy in 4 fractions over 1 week for patients with renal cell carcinoma

A Phase I/II clinical trial of Carbon-ion radiotherapy in 4 fractions over 1 week for patients with renal cell carcinoma - Carbon-ion radiotherapy in 4 fractions for patients with renal cell carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029469

Enrollment

Registered

2017-10-10

Start date

2017-10-10

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

Renal cell carcinoma

Interventions

Carbon-ion radiotherapy 55.2 Gy (RBE) in 4 fractions within 1 week, increased to 60.0Gy(RBE)from 6th case.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) biopsy-proven, or imaging diagnosed renal cell carcinoma 2) historogy: clear cell carcinoma, chromophobe cell carcinoma, or papillary renal cell carcinoma 3) untreated T1/T2, or T3/T4 without tumor emboli. In addition, N1M1 case with long term prognosis (according to TNM classification 2016). 4) an age >= 20 5) Performance Status (ECOG): 0-1 6)documented informed consent

Exclusion criteria

Exclusion criteria: 1)target area that had been treated by other radiation therapy 2) After the start of molecular targetting therapy 3) irradiated dose to gastrointestinal tract is more than 60% of prescribed dose 4) maximum tumor diameter > 15cm 5) dialyzed RCC 6) presence of active double cancers other than RCC 7) serious medical or psychological condition precluding the safe administration of the treatment

Design outcomes

Primary

Measure	Time frame
Acute adverse effect (within 90 days)	—

Secondary

Measure	Time frame
late adverse effect, local control, cancer specific survival, overall survival, QOL	—

Countries

Japan

Contacts

Public ContactGoro Kasuya

National Institutes for Quantum Science and Technology QST hospital

kasuya.goro@qst.go.jp043-206-3360

Outcome results

None listed

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