NCT05304468

Brief Summary

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

Trial Health

75
On Track

Trial Health Score

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

Enrollment
452

participants targeted

Target at P50-P75 for phase_3

Timeline
42mo left

Started May 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not 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 Progress53%
May 2022Oct 2029

First Submitted

Initial submission to the registry

March 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2029

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

March 28, 2022

Last Update Submit

March 18, 2025

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinomaradiotherapyinduction chemotherapy

Outcome Measures

Primary Outcomes (1)

  • PFS (progression-free survival)

    Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.

    2 year

Secondary Outcomes (7)

  • Overall Survival(OS)

    2 year

  • Locoregional relapse-free survival(LRFS)

    2 year

  • Distant metastasis-free survival(DMFS)

    2 year

  • Overall response rate

    3 months

  • Incidence rate of adverse events (AEs)

    2 year

  • +2 more secondary outcomes

Study Arms (2)

Reduced-dose group

EXPERIMENTAL

After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.

Radiation: IMRTDrug: induction chemotherapyDrug: cisplatin concurrent chemotherapy

Standard dose group

ACTIVE COMPARATOR

After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.

Radiation: IMRTDrug: induction chemotherapyDrug: cisplatin concurrent chemotherapy

Interventions

IMRTRADIATION

Patients in experimental group received reduced dose IMRT

Reduced-dose groupStandard dose group
induction chemotherapyDRUG

cisplatin-based induction chemotherapy for two cycles

Reduced-dose groupStandard dose group
cisplatin concurrent chemotherapyDRUG

cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Reduced-dose groupStandard dose group

Eligibility Criteria

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

You may qualify if:

  • Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
  • Stage II-III（8thAJCC/UICC staging system)
  • Aged 18-70 years
  • ECOG = 0-1
  • HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
  • ALT,AST\<1.5 x ULN；TBIL\<1.5×ULN
  • CCR≥60ml/min or Cr\<1.5×ULN
  • CR/PR and EBVDNA undetectable after induction chemotherapy
  • Signed informed consent

You may not qualify if:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
  • Age \<18 or \>70years
  • Treatment with palliative intent
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
  • Pregnancy or lactation
  • History of previous radiotherapy (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, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsRemission Induction

Study Officials

  • Hai Qiang Mai, Dr

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: phase III non-inferiority
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2022

First Posted

March 31, 2022

Study Start

May 11, 2022

Primary Completion (Estimated)

October 29, 2026

Study Completion (Estimated)

October 29, 2029

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations

CN(1)