Skip to content

Salvage surgery versus pulsed low-dose IMRT radiotherapy for recurrent laryngopharyngeal carcinoma patients after radiotherapy: a phase II multicenter controlled trial

Salvage surgery versus pulsed low-dose IMRT radiotherapy for recurrent laryngopharyngeal carcinoma patients after radiotherapy: a phase II multicenter controlled trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021494
Enrollment
Unknown
Registered
2019-02-23
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Recurrent Laryngopharyngeal Carcinoma after radiotherapy

Interventions

Group 1:Salvage Surgery
Group 2:PLDR

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0-2; 3. Consciousness is clear and can cooperate with treatment; 4. Recurrent laryngopharyngeal cancer confirmed by pathology; 5. Previous information of surgery and radiotherapy can be obtained, including operation mode, operation scope, total dose of target area, segmentation mode, dose distribution, radiation dose to normal tissue and isodose curve, etc.; 6. With operative indications; 7. With radiotherapy indications; There are measurable solid tumors (efficacy evaluation criteria: RECIST 1.1); 8. Women of childbearing age must be in a non-pregnant state (pregnancy test is negative, menopausal women are considered infertile after 12 months of menopause). Women and men of childbearing age should take effective contraceptive measures during the study period and within 3 months after the end of the study; 9. Absolute neutrophil count (ANC) > 1.0*10^9/L; 10. Platelet (PLT) > 75*10^9/L; 11. Subjects must sign a written informed consent and be willing to participate in and complete the study and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent overradiation therapy for the lesion within 3 months before entering this study; 2. History of telangiectatic ataxia or other radiosensitivity reactions in the past; 3. Scleroderma or active connective tissue disease; 4. Severe and uncontrollable infectious diseases; 5. Complications with severe mental illness or psychological disorders, central nervous system disorders, cardiovascular and cerebrovascular complications, epilepsy and other diseases may limit their understanding, implementation and treatment compliance with informed consent; 6. With distant metastasis; 7. With operative contraindications; 8. With radiotherapy contraindication; 9. Researchers believe any other physical condition that increases the risk of radiation-related toxicity.

Design outcomes

Primary

MeasureTime frame
Local control rate;OS;

Secondary

MeasureTime frame
Quality of life;

Countries

China

Contacts

Public ContactZhang Peng

Sichuan Cancer Hospital

izhangpeng@163.com+86 13668200277

Outcome results

None listed

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