NCT06912698

Brief Summary

This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P50-P75 for phase_3

Timeline
83mo left

Started May 2025

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2025Mar 2033

First Submitted

Initial submission to the registry

April 3, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2031

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2033

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

5.9 years

First QC Date

April 3, 2025

Last Update Submit

April 16, 2025

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

radiotherapydose

Outcome Measures

Primary Outcomes (1)

  • Locoregional relapse-free survival

    The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first.

    3 year

Secondary Outcomes (5)

  • Progression-free survival

    3 year

  • Overall survival

    3 year

  • Distant metastasis-free survival

    3 year

  • Incidence rate of adverse events (AEs)

    3 year

  • Change of quality of life (QoL) score

    1 year

Study Arms (2)

Reduced dose group

EXPERIMENTAL

Patients receive reduced dose radiotherapy.

Radiation: Reduced dose radiation

Standard dose group

ACTIVE COMPARATOR

Patients receive standard dose radiotherapy.

Radiation: Standard dose radiation

Interventions

Reduced dose radiationRADIATION

Reduced dose group would receive 61.48Gy radiation.

Reduced dose group
Standard dose radiationRADIATION

Standard dose group would receive 69.96Gy radiation.

Standard dose group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70, regardless of sex.
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer\[AJCC\] edition).
  • Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
  • ECOG (Eastern Cooperative Oncology Group) score: 0-1.
  • Women in their reproductive years should ensure that they use contraception during the study period.
  • Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
  • Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.5×ULN.
  • Renal function: serum creatinine \<1.5×ULN or creatinine clearance rate≥60mL/min.
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

You may not qualify if:

  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
  • Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
  • Receiving radiotherapy or chemotherapy or targeted therapy previously.
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
  • Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  • Severe, uncontrolled medical conditions and infections.
  • At the same time using other test drugs or in other clinical trials.
  • Refusal or inability to sign informed consent to participate in the trial.
  • Other treatment contraindications.
  • Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • Mayr NA, Magnotta VA, Ehrhardt JC, Wheeler JA, Sorosky JI, Wen BC, Davis CS, Pelsang RE, Anderson B, Doornbos JF, Hussey DH, Yuh WT. Usefulness of tumor volumetry by magnetic resonance imaging in assessing response to radiation therapy in carcinoma of the uterine cervix. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):915-24. doi: 10.1016/0360-3016(96)00230-1.

    PMID: 8751400BACKGROUND

  • Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6.

    PMID: 32272183BACKGROUND

  • Pan JJ, Mai HQ, Ng WT, Hu CS, Li JG, Chen XZ, Chow JCH, Wong E, Lee V, Ma LY, Guo QJ, Liu Q, Liu LZ, Xu TT, Gong XC, Qiang MY, Au KH, Liu TC, Chiang CL, Xiao YP, Lin SJ, Chen YB, Guo SS, Wong CHL, Tang LQ, Xu ZY, Jia YZ, Peng WS, Hu LP, Lu TZ, Jiang F, Cao CN, Xu W, Ma J, Blanchard P, Williams M, Glastonbury CM, King AD, Patel SG, Seethala RR, Colevas AD, Fan DM, Chua MLK, Huang SH, O'Sullivan B, Lydiatt W, Lee AWM. Ninth Version of the AJCC and UICC Nasopharyngeal Cancer TNM Staging Classification. JAMA Oncol. 2024 Oct 10;10(12):1627-35. doi: 10.1001/jamaoncol.2024.4354. Online ahead of print.

    PMID: 39388190BACKGROUND

  • Rischin D, Corry J, Smith J, Stewart J, Hughes P, Peters L. Excellent disease control and survival in patients with advanced nasopharyngeal cancer treated with chemoradiation. J Clin Oncol. 2002 Apr 1;20(7):1845-52. doi: 10.1200/JCO.2002.07.011.

    PMID: 11919243BACKGROUND

  • Songthong AP, Kannarunimit D, Chakkabat C, Lertbutsayanukul C. A randomized phase II/III study of adverse events between sequential (SEQ) versus simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) in nasopharyngeal carcinoma; preliminary result on acute adverse events. Radiat Oncol. 2015 Aug 8;10:166. doi: 10.1186/s13014-015-0472-y.

    PMID: 26253488BACKGROUND

Related Links

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Hai-Qiang MD, Dr.

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Hai-Qiang Mai, Dr.

CONTACT

+8602087343380maihq@sysucc.org.cn

Qiu-Yan Chen, Dr.

CONTACT

+8602087343380chenqy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 6, 2025

Study Start

May 22, 2025

Primary Completion (Estimated)

April 19, 2031

Study Completion (Estimated)

March 19, 2033

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

CN(1)