Status:
UNKNOWN
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-cau...
Detailed Description
In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irr...
Eligibility Criteria
Inclusion
- Patients without medial group retropharyngeal node metastasis;
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
- Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
- No evidence of distant metastasis (M0);
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- Patients with medial group retropharyngeal node metastasis;
- Aged \> 65 or \< 18;
- Treatment with palliative intent;
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
- With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume);
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes;
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT03346109
Start Date
November 16 2017
End Date
December 30 2022
Last Update
April 6 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060