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A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026727
Enrollment
Unknown
Registered
2019-10-20
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

recurrent nasopharyngeal carcinoma

Interventions

Sponsors

Eye, Ear, Nose, and Throat Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study; 2.Stage T1 or T2 according to AJCC 8th edition ; 3.Aged 18 to 70 years; 4.Without metastasis; 5.previously received 1 course of radiotherapy;Without radiotherapy within 1 year, without local treatment for recurrent disease; 6.Surgical resectable and IMRT suitable; 7.If regional recurrence presented, regional lesion can be treated with local treatments. 8.ECOG score 0 or 1; 9.Sufficient organ function; 10.Acceptable approach of contraception.

Exclusion criteria

Exclusion criteria: 1.Refuse to sign inform consent; 2.Radiation encephalopathy or leptomeningeal disease (LMD); 3.History of radioactive particle planting; 4.Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy; 5.With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer); 6.Any contradiction to surgery; 7.Have any co-existing condition that would preclude full compliance or safety with the study; 8.Presence of a significant neurological or psychiatric disease, including dementia and seizures; 9.Uncontrolled infectious diseases; 10.Female patients who are at pregnancy or lactation. 11.Without personal freedom or independent civil capacity. 12.With serious autoimmune disease. 13.Participants of other interventional clinical trial.

Design outcomes

Primary

MeasureTime frame
3 year overall survival (OS);

Secondary

MeasureTime frame
progression free survival;Local progression free survival;Regional progression free survival;Distant metastasis free survival;Toxicities;life quality;

Countries

China

Contacts

Public ContactHongmeng Yu

Eye, Ear, Nose, and Throat Hospital, Fudan University

hongmengyush@fudan.edu.cn+86 021 64377134

Outcome results

None listed

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