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Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013392
Enrollment
Unknown
Registered
2017-11-15
Start date
2017-11-13
Completion date
Unknown
Last updated
2017-11-20

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

Conditions

Nasopharyngeal carcinoma

Interventions

Experimental group:Medial Group Retropharyngeal Node Sparing
Active Comparator:Medial Group Retropharyngeal Node with Prophylactic Irradiation

Sponsors

Cancer Center, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients without medial group retropharyngeal node metastasis; 2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); 3. Tumor staged as T1-4N0-3(according to the 8th AJCC edition); 4. No evidence of distant metastasis (M0); 5. Satisfactory performance status: Karnofsky scale (KPS) = 70; 6. Patients must be informed of the investigational nature of this study and give written informed consent.;Inclusion criteria: 1. Patients without medial group retropharyngeal node metastasis; 2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); 3. Tumor staged as T1-4N0-3(according to the 8th AJCC edition); 4. No evidence of distant metastasis (M0); 5. Satisfactory performance status: Karnofsky scale (KPS) = 70; 6. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with medial group retropharyngeal node metastasis; 2. Aged > 65 or 65 or < 18; 3. Treatment with palliative intent; 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer; 5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 6. With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes; 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.

Design outcomes

Primary

MeasureTime frame
Local replase-free survival rate;;Local replase-free survival rate;

Secondary

MeasureTime frame
Incidence of acute and late toxicity;Incidence of out-field recurrence rate;Dysphagia related quality of life;Overall survival;;Incidence of acute and late toxicity;Incidence of out-field recurrence rate;Dysphagia related quality of life;Overall survival;

Countries

China

Contacts

Public ContactYanping Mao;Yanping Mao ;

Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University;Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University

maoyp@sysucc.org.cn;maoyp@sysucc.org.cn+86 20 13500019575;+86 20 13500019575

Outcome results

None listed

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