Multi-center prospective clinical study for the stratery of surgery combined proton heavy ion radiotherapy and chemotherapy treatment of head and neck soft tissue sarcoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIN-17011981

Enrollment

Unknown

Registered

2017-07-13

Start date

2020-09-30

Completion date

Unknown

Last updated

2017-07-17

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

Conditions

head and neck soft tissue sarcoma

Interventions

The experimental group:Surgery+proton heavy ion radiotherapy + postoperative adjuvant chemotherapy

The control group:Surgery+ conventional photon radiation therapy plus postoperative adjuvant chemotherapy

Eligibility

Sex/Gender

All

Age

14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =14 years old male and female; 2. Pathological biopsy confirming soft tissue sarcoma (Head and neck region) with resectable lesions; 3. No distant metastatic disease and other cancers (PET scan); 4. Treatment history: Havent received radiotherapy or chemotherapy or radical operarion previously; 5. Karnofsky performance status (KPS) >60; Pathological biopsy confirming soft tissue sarcoma (Head and neck region) with resectable lesions; Adequate hematologic function: White blood cell (WBC) >3,000/mm3, Hemoglobin (HB)>90g/L, Platelet count (PLT)>80,000/mm3. Absolute neutrophil count (ANC0)>1500/mm3; Hepatic function: ALAT(alanine aminotransferase)/ASAT(aspartate transaminase ) 50ml/min (Cockcroft-Gault), Glomendar filtration rate (GFR) >80ml/min; 6. Cardiac function: Ejection fraction within 55%-75%; 7. Pulmonary function: Pulmonary ventilation exchange rate (PVE)>50%; 8. Other clinical trail: Havent join other clinical trail within the last 6 months; 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Age: 2.5 times the upper limit of normal (ULN), bilirubin >1.5 times ULN Renal function: Serum creatinine (Cr) >1.5 times ULN. Creatinine?clearance rate (Ccr) 75% Pulmonary function: Pulmonary ventilation exchange rate (PVE)< 50% 8.Other clinical trail: Joined other clinical trail within the last 6 months 9. Patient has a history of psychiatric drugs abuse and can't quit or patients with mental disorders 10. According to the judgement of researcher, there are disease or reason may have influence of the patient which will forbidden the patient finishing the research. 11 Not written informed consent

Design outcomes

Primary

Measure	Time frame
the 2 years overall survival;	—

Countries

China

Contacts

Public ContactJi Tong

Affiliated 9th People's Hospital School of Medicine, Shanghai Jiao Tong University

jitongjitong@foxmail.com+86 13651658767

Outcome results

None listed

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