NCT04448522

Brief Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P50-P75 for phase_3

Timeline
27mo left

Started Aug 2020

Longer than P75 for phase_3

Geographic Reach
2 countries

6 active sites

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 Progress72%
Aug 2020Aug 2028

First Submitted

Initial submission to the registry

June 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

6 years

First QC Date

June 24, 2020

Last Update Submit

September 24, 2020

Conditions

Nasopharyngeal CarcinomaRadiotherapyChemotherapy

Keywords

Nasopharyngeal carcinomaintensity-modulated radiotherapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival (PFS)

    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

    3 years

Secondary Outcomes (7)

  • Overall Survival (OS)

    3 years

  • Distant Metastasis-Free Survival (DMFS)

    3 years

  • Locoregional Relapse-Free Survival (LRRFS)

    3 years

  • Incidence of treatment related acute complications

    up to 1 years

  • Incidence of treatment related late complications

    up to 3 years

  • +2 more secondary outcomes

Study Arms (2)

Reduced dosage IMRT group

EXPERIMENTAL

3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy

Radiation: reduced dosage IMRT

Conventional dosage IMRT group

ACTIVE COMPARATOR

3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy

Radiation: conventional dosage IMRT

Interventions

reduced dosage IMRTRADIATION

1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx：63.6Gy/30Fr/2.12Gy; PTVnd：63.6Gy/30Fr/2.12Gy; PTV1：54Gy/30Fr/1.8Gy; PTV2：49.2Gy/30Fr/1.64Gy

Reduced dosage IMRT group
conventional dosage IMRTRADIATION

1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx：69.96Gy/33Fr/2.12Gy; PTVnd：69.96Gy/33Fr/2.12Gy; PTV1：59.4Gy/33Fr/1.8Gy; PTV2：54Gy/33Fr/1.64Gy

Conventional dosage IMRT group

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
  • Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
  • Aged between 18-70 years.
  • Karnofsky scale (KPS)≥70.
  • Normal bone marrow function.
  • Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
  • EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
  • Normal liver and kidney function:
  • total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
  • creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
  • Given written informed consent.

You may not qualify if:

  • Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
  • Recurrent or metastatic nasopharyngeal carcinoma.
  • Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
  • EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
  • Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
  • Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
  • Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
  • Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5×ULN), and mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

NOT YET RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, 512025, China

NOT YET RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

NOT YET RECRUITING

National Cancer Centre Singapore

Singapore, 169610, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-87343624chmingy@mail.sysu.edu.cn

Rui You, MD, PhD

CONTACT

86-13580439820yourui@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
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 26, 2020

Study Start

August 18, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2028

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

SG(1)CN(5)