Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Dec 31, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the best treatment option for patients with recurrent nasopharyngeal cancer, which is a type of cancer that comes back after initial treatment. Researchers are comparing two approaches: surgery using a special technique called endonasal endoscopic surgery and a type of radiation therapy known as Intensity-Modulated Radiation Therapy (IMRT). The goal is to see which method helps patients live longer and stay free of cancer, while also checking for side effects from each treatment.

To be eligible for this trial, participants need to be between 18 and 70 years old, have been diagnosed with recurrent nasopharyngeal cancer that has not spread to other parts of the body, and have previously received one course of radiation therapy. They should also be physically fit enough to undergo surgery or IMRT. If you decide to participate, you can expect close monitoring and support throughout the treatment process. It’s important to know that the study is not yet recruiting, so there will be more information available soon if you or someone you know might be interested.

Gender

ALL

Eligibility 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;
• • 6. Without radiotherapy within 1 year, without local treatment for recurrent disease;
• • 7. Surgical resectable and IMRT suitable;
• • 8. If regional recurrence presented, regional lesion can be treated with local treatments.
• • 9. ECOG score 0 or 1;
• • 10. Sufficient organ function;
• • 11. Acceptable approach of contraception.
• 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.