Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT (NCT04215510) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
China286 participantsStarted 2021-03-01
Plain-language summary
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
✓. Stage T1 or T2 according to AJCC 8th edition ;
✓. Aged 18 to 70 years;
✓. Without metastasis;
✓. previously received 1 course of radiotherapy;
✓. Without radiotherapy within 1 year, without local treatment for recurrent disease;
✓. Surgical resectable and IMRT suitable;
✓. If regional recurrence presented, regional lesion can be treated with local treatments.
Exclusion criteria
✕. Refuse to sign inform consent;
✕. Radiation encephalopathy or leptomeningeal disease (LMD);
✕. History of radioactive particle planting;
✕. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
✕. With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
✕. Any contradiction to surgery;
What they're measuring
1
3 year Overall Survival (OS) rate
Timeframe: From date of randomization until the date of death from any cause,through study completion,up to 3 years.