A prospective phase II randomized controlled clinical trial of proton vs. carbon ion radiotherapy for skull base chordoma/chondrosarcoma

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036688

Enrollment

Unknown

Registered

2020-08-24

Start date

2018-07-01

Completion date

Unknown

Last updated

2020-09-21

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

Conditions

Skull base chordoma/chondrosarcoma

Interventions

Proton radiation therapy group:Proton radiation therapy

Carbon ion radiation therapy group:Carbon ion radiation therap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 18~65 years; 2) The pathology is diagnosed as classic/chondral skull base chordoma or chondrosarcoma; 3) Undergoing partial resection or biopsy, tumor residues can be seen on imaging; 4) Patients who relapse after surgery and refuse surgery; 5) Expected survival at least 6 months; 6) ECOG score 0-1; 7) Routine examination of peripheral blood before treatment meets the following conditions: neutrophil count>2000/mm3, platelet count>100,000/mm3; 8) The liver and kidney function test before treatment meets the following conditions: bilirubin 60 ml/min; 9) Sign the informed consent form before starting the research.

Exclusion criteria

Exclusion criteria: 1) With history of radiation therapy; 2) Accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease or other complications that may affect the progress of radiotherapy; 3) Imaging examination shows dissemination in the distance; 4) Have received radioactive seed implantation in the treatment area; 5) A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma); 6) Positive pregnancy test for women of childbearing age; 7) At the same time, accompanied by diseases or conditions that affect the safety of patients during normal enrollment or research; 8) Active mental disorders or other mental disorders that affect the patient's ability to sign informed consent and understand; 9) Uncontrolled active infection.

Design outcomes

Primary

Measure	Time frame
Local relapse-free survival;	—

Secondary

Measure	Time frame
Overall survival;Progression-free survival;Toxicities;Quality of life;	—

Countries

China

Contacts

Public ContactJing Yang

Shanghai Proton and Heavy Ion Center

jing.yang@sphic.org.cn+86 18218445561

Outcome results

None listed

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