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Prospective phase I/II clinical study of heavy ion therapy for muscular-infiltrating bladder cancer

Prospective phase I/II clinical study of heavy ion therapy for muscular-infiltrating bladder cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043607
Enrollment
Unknown
Registered
2021-02-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

Bladder cancer

Interventions

Sponsors

Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Ability to follow the plan and sign the informed consent; There are complications that are not suitable for radical cystectomy or the patient refuses to undergo radical cystectomy; Aged between 18 and 80 years; Diagnosed with muscular invasive bladder cancer by cystoscopy and biopsy; No bilateral ureteral obstruction; No photon radiotherapy within six months before this radiotherapy; Metastasis was excluded by imaging evaluation; KPS score >= 60, andECOG general status score is 0-1 ; The anticipated survival will be >=12 months; Adequate organ function; The position of the lesions can meet the requirements of the design of the radiation field; Patients can hold their positions for more than 30 minutes as the treacment requires.

Exclusion criteria

Exclusion criteria: Accompanied with other malignant tumors which were not well controlled; The treatment area has received any radioactive seed implantation treatment; The dose limit of the organ at risk cannot reach the preset safe dose limit; The normal function may be interfered with by high-energy rays or the radiation target regional dose may be affected by metal prosthetic implants; Doctors think that carbon ion radiotherapy will not benefit the patient; Have diseases that may affect the treatment of carbon ions; Accompanied with serious complications that may affect carbon ion therapy; Unable to understand the purpose of treatment or unwilling/unable to sign informed consent; No capacity for civil conduct or limited capacity for civil conduct. Other situations thatphysicians do not think it is appropriate to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
Dose Limited Toxicity;Local control;Progression-free survival;

Countries

China

Contacts

Public ContactYanshan Zhang

Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 13830510999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026