ClinicalTrials.gg
Not yet recruitingNCT07789158Updated Aug 27, 2026

Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma

A Phase 2 interventional study of reduced dose group and Standard Dose Group in Nasopharyngeal Carcinoma (NPC), sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
269
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 26 studies in Nasopharyngeal Carcinoma by Fudan University — 12 open to participants now, 13 under way, 4 of them phase 3. Nasopharyngeal Carcinoma · Fudan University.

Planned enrollment
5th of 24
269 · median 70
Started
2026
with 1 other
Phase 2
15 of 26
5 open now
Primary completion
2031-08
later than 12 of 12 live
Registered
26th of 26
by date

Among the 26 studies in Nasopharyngeal Carcinoma by Fudan University, this one is the 5th largest by planned enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2026, is one of 15 in phase 2, reaches primary completion later than 12 of the 12 other live ones, and was the 26th registered.

Nasopharyngeal Carcinoma

683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.

Browse Nasopharyngeal Carcinoma studies →

Open to participants now

12 of the 26 studies in Nasopharyngeal Carcinoma by Fudan University are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Nasopharyngeal Carcinoma by Fudan University, or all of them as a file.
02

Study summary

To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).

Read the detailed description

This study focused on patients with AJCC/UICC 9th edition stage IB-II(The participants were required to have no extensive skull base invasion and lymph nodes \< 4 cm before treatment). It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy/27 fractions group and the 66.0 Gy/30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR > 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.

03

Conditions studied

  • Nasopharyngeal Carcinoma (NPC)

Keywords

  • Nasopharyngeal Carcinoma
  • EBV DNA
  • MRI
  • reduced dose radiotherapy
  • induction chemotherapy
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18 - 65 years old.
  • confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer.
  • AJCC/UICC 9th edition stage IB-II untreated non- nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be \< 22 mL; N1-2 requires baseline lymph nodes \< 4 cm).
  • Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed.
  • performance status 0 - 1 points.
  • Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\^9/L, ≥ 100 × 10\^9/L, ≥ 90 g/L; /AST ≤ 2.5 × , total ≤ 1.5 × ULN; rate ≥ 60 mL/min.
  • Sign a written form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol.

Exclusion criteria

Exclusion Criteria:

  • to T4, N3 or distant sites; AJCC/UICC 9th edition stage III-IV.
  • Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic ).
  • Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective measures.
  • Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance.
  • Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
  • Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
269 participants (estimated)

Study arms

  • Experimental
    Experimental group

    reduced dose group

    Radiation: reduced dose group

  • Active comparator
    Control group

    standard dose group

    Radiation: Standard Dose Group

  • Other
    Corhort 2

    Other: concurrent chemoradiotherapy

Interventions

  • Radiationreduced dose group

    59.4 Gy/27F

  • RadiationStandard Dose Group

    66 Gy/30F

  • Otherconcurrent chemoradiotherapy

    66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2

06

What researchers measure

Primary outcomes

  1. 2-year Locoregional Failure-Free Survival,2-y LRFFS

    The time from enrollment to the first local or regional failure or any cause of death is determined by the event that occurs first. For those who did not experience any of these events, they are censored at the last valid follow-up date.

    Time frame: 2 year

Secondary outcomes

  1. 2-year Failure-Free Survival,2-y FFS

    The time from enrollment to the first occurrence of local regional failure, distant metastasis, or death due to any cause is determined by the event that occurs first.

    Time frame: 2 year

  2. 2-year Overall Survival,2-y OS

    The time from enrollment to any cause of death; for those who were still alive at the end of the follow-up, the data are censored at the date of the last confirmed survival.

    Time frame: 2 year

  3. 2-year Distant Failure-Free Survival,2-y DFFS

    The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first.

    Time frame: 2 year

  4. Acute Adverse Events,acute AEs

    The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy.

    Time frame: up to 90 days after radiotherapy

  5. Late Adverse Events,late AEs

    After 90 days of radiotherapy, the evaluation was conducted according to CTCAE v5.0 and RTOG/EORTC standards for late radiation injury.

    Time frame: After 90 days of radiotherapy to the date of death,assessed up to 2 years or more.

  6. Quality of Life,QoL (EORTC QLQ-H&N35)

    Changes in QoL of participants from baseline to up to 6 months after the completion of radiotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). Higher scores mean a worse outcome.

    Time frame: baseline and up to one year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2031, 59 months later.

Of 128 non-industry phase 2 interventional studies under Nasopharyngeal Carcinoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 74. This study's planned 59 months is above that.

Counting every sponsor, half of 143 studies reached it within 43 months; a quarter within 28 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Aug 27, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Aug 31, 2031
CompletionEst.
Aug 31, 2031
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789158
Lead sponsor
Fudan University
Responsible party
Chaosu Hu (Principal Investigator, Fudan University) — Principal investigator
First posted
Aug 27, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 31, 2031 (estimated)
Completion
Aug 31, 2031 (estimated)
Last update
Aug 27, 2026

Study contacts

Xiayun He, MD
Contact
hexiayun1962@163.com
+86021-64175590-81412
Fen Xue, MD
Contact
dr_fenxue@163.com
+8618916882304
Xiayun He
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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