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Nasopharyngeal CarcinomaPhase 3NCT04448522

Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma

A Phase 3 study testing reduced dosage IMRT and conventional dosage IMRT in people with Nasopharyngeal Carcinoma and Radiotherapy, run by Sun Yat-sen University at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
reduced dosage IMRT and conventional dosage IMRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
6 sitesin 2 countries
Study dates
18 Aug 2020to Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Ming-Yuan Chen, MD, PhD contact

86-20-87343624

chmingy@mail.sysu.edu.cn

Rui You, MD, PhD contact

86-13580439820

yourui@sysucc.org.cn

6 sites in 2 countries

China5 sites, 5 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming-Yuan Chen, MD, PhD, 86-20-8734-3361, chmingy@mail.sysu.edu.cn

    Rui You, MD, PhD, 86-13580439820, yourui@sysucc.org.cn

    Recruiting

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Dong-Ping Chen, MD, 86-13302215492, chen_dpgz@163.com

    Bin Qi, PhD, qibin020@126.com

    Not yet recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512025

    Su-Ming Pan, MD, 86-13826331948

    Xiang-Guo Zhang, MD, 86-13826380511, 1178906911@qq.com

    Not yet recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, 543002

    Jin-Hui Liang, MD, 86-13878480806

    Jin-Hui Liang, MD

    Not yet recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

    Feng Lei, MD, 86-18933345382

    Feng Lei, MD

    Recruiting

Other trials in China

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore

    Singapore, 169610

    Melvin Lee Kiang Chua, PhD, 65-6436-8000, melvin.chua.l.k@singhealth.com.sg

    Melvin Lee Kiang Chua, PhD

    Not yet recruiting

Other trials in Singapore

About this study

Official title: A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma

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)

Read the detailed description

Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.

Being tested
reduced dosage IMRT, conventional dosage IMRT
Keywords
Nasopharyngeal carcinoma, intensity-modulated radiotherapy, chemotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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
Study groups in NCT04448522
Study groupRoleWhat they receive
Reduced dosage IMRT groupExperimental3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy
Receives: Radiation: reduced dosage IMRT
Conventional dosage IMRT groupActive comparator3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy
Receives: Radiation: conventional dosage IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progress-free survival (PFS)

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

    Measured: 3 years

Secondary outcomes (7)

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Measured: 3 years

  2. Distant Metastasis-Free Survival (DMFS)

    Defined as the time interval from randomisation to the date of first distant metastases.

    Measured: 3 years

  3. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from randomisation to the date of first locoregional relapse.

    Measured: 3 years

  4. Incidence of treatment related acute complications

    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: up to 1 years

  5. Incidence of treatment related late complications

    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: up to 3 years

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

    Measured: up to 3 years

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start18 Aug 2020
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
508 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448522
Sponsor's protocol ID
SYSUCC-MYC-2020-1201
Status last verified
Sep 2020
First submitted
24 Jun 2020
Last updated
28 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing reduced dosage IMRT and conventional dosage IMRT in people with Nasopharyngeal Carcinoma and Radiotherapy, run by Sun Yat-sen University at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-Yuan Chen, MD, PhD (86-20-87343624, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.

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