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Nasopharyngeal CarcinomaPhase 3NCT05304468

Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

A Phase 3 study testing IMRT, induction chemotherapy and cisplatin concurrent chemotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
IMRT, induction chemotherapy and cisplatin concurrent chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
1 siteChina
Study dates
11 May 2022to 29 Oct 2029
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

  • 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
Show all 9Show fewer
  • CCR≥60ml/min or Cr<1.5×ULN
  • CR/PR and EBVDNA undetectable after induction chemotherapy
  • Signed informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Universitty Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy

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

Read the detailed description

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Being tested
IMRT, induction chemotherapy, cisplatin concurrent chemotherapy
Keywords
Nasopharyngeal Carcinoma, radiotherapy, induction 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.

  • IMRTRadiation

    Patients in experimental group received reduced dose IMRT

  • induction chemotherapyDrug

    cisplatin-based induction chemotherapy for two cycles

  • cisplatin concurrent chemotherapyDrug

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

Study groups in NCT05304468
Study groupRoleWhat they receive
Reduced-dose groupExperimentalAfter 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.
Receives: Radiation: IMRT; Drug: induction chemotherapy; Drug: cisplatin concurrent chemotherapy
Standard dose groupActive comparatorAfter 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.
Receives: Radiation: IMRT; Drug: induction chemotherapy; Drug: cisplatin concurrent chemotherapy

What is being measured

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

  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.

    Measured: 2 year

Secondary outcomes (7)

  1. Overall Survival(OS)

    Defined as the time from randomization to death from any cause

    Measured: 2 year

  2. Locoregional relapse-free survival(LRFS)

    Defined as the time from randomization to the first local or regional recurrence, or death from any cause.

    follow-up visit.

    Measured: 2 year

  3. Distant metastasis-free survival(DMFS)

    Defined as the time from randomization to the first distant metastasis or death from any cause.

    Measured: 2 year

  4. Overall response rate

    Tumour response rate was classified according to RECIST, version 1.1

    Measured: 3 months

  5. Incidence rate of adverse events (AEs)

    Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

    Measured: 2 year

  6. Change of QoL

    QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

    Measured: 1 year

  7. Change of EORTC quality of life questionnaire(QLQ) Head and Neck score

    QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H\&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva,coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.All of the scores mentioned above were assessed at the below time point:before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

    Measured: 1 year

Timeline

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

  1. First posted31 Mar 2022
  2. Study start11 May 2022
  3. Primary completion29 Oct 2026 (estimated)
  4. Study completion29 Oct 2029 (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
Model description
phase III non-inferiority
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304468
Sponsor's protocol ID
2022-FXY-017
Status last verified
Mar 2025
First submitted
28 Mar 2022
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMRT, induction chemotherapy and cisplatin concurrent chemotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (progression-free survival) (time frame: 2 year). 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 NCT05304468.

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 21 Mar 2025.

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