To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

NCT ID: NCT03346109

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2022-12-30

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-caused dysphagia and improve patients' quality of life without compromising survival rate.

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 irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRLN sparing group

Patients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr

Group Type: EXPERIMENTAL

medial group retropharyngeal node（MRLN） sparing

Intervention Type: RADIATION

Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.

MRLN prophylactic irradiation group

Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

medial group retropharyngeal node（MRLN） sparing

Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.

Intervention Type: RADIATION

Eligibility 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.

Exclusion Criteria

1. Patients with medial group retropharyngeal node metastasis;

2. Aged > 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ma, M.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.

Reference Type: DERIVED

PMID: 36746459 (View on PubMed)

Other Identifiers

2017-FXY-114

Identifier Type: -

Identifier Source: org_study_id