ClinicalTrials.gg
RecruitingNCT05994170CTVp1-NPCUpdated Aug 16, 2023

Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma

An interventional study of Reduction CTVp1 and Non-reduction CTVp1 in Nasopharyngeal Carcinoma and Intensity-Modulated Radiotherapy, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by Zhongshan People's Hospital, Guangdong, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
454
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

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

Among 489 studies in Nasopharyngeal Carcinoma with a site in China — 203 open to participants now, 254 under way, 86 of them phase 3. Nasopharyngeal Carcinoma · China.

Planned enrollment
52nd of 417
454 · median 126
Started
2023
with 43 others
No phase
54 of 489
25 open now
Primary completion
2026-08
later than 119 of 253 live
Registered
348th of 489
by date

Among the 489 studies in Nasopharyngeal Carcinoma with a site in China, this one is the 52nd largest by planned enrollment of the 417 interventional ones that give a count, is one of 44 that started in 2023, is one of 54 with no phase, reaches primary completion later than 119 of the 253 other live ones, and was the 348th 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

203 of the 489 studies in Nasopharyngeal Carcinoma with a site in China are open now. Recruiting first, the newest first:

198 more — sign in →

All 203 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

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 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.

Read the detailed description

This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.

03

Conditions studied

  • Nasopharyngeal Carcinoma
  • Intensity-Modulated Radiotherapy
04

Who can participate

Ages eligible
18 Years to 70 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

  1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
  2. newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
  3. nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
  4. planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0:No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies,node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
  5. no previous treatment for cancer;
  6. a performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
  7. between 18 and 70 years old;
  8. adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, count ≥ 100×10E9/L;Adequate liver function: and AST ≤ 2.5×, ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous ≥ 60ml/min (Cockcroft-Gault formula);
  9. Patients must be informed of the nature of this study and give written .

Exclusion criteria

Exclusion Criteria:

  1. receipt of treatment with palliative intent;
  2. receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
  3. had disease progress after chemotherapy in local advantage NPC
  4. presence of distant ;
  5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
  6. Prior except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
  7. Have (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or arrhythmia that requires treatment;
  8. lactation or pregnancy;
  9. Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.
Terms in these criteria, in plain language(14)

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.

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

Metastases

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

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
454 participants (estimated)

Study arms

  • Experimental
    Reduction CTVp1

    CTVp1=GTVp+5mm

    Radiation: Reduction CTVp1

  • Placebo comparator
    Non-reduction CTVp1

    CTVp1=GTVp+5mm+whole nasopharynx

    Radiation: Non-reduction CTVp1

Interventions

  • RadiationReduction CTVp1

    High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)

  • RadiationNon-reduction CTVp1

    High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)

06

What researchers measure

Primary outcomes

  1. Local Relapse-free Survival(LRFS)

    the time from randomization to documented local recurrence or death from any cause

    Time frame: 3 years

  2. Incidence of hearing impairment worse than graded 2

    audiometry and symptoms graded according to the CTCAE (version 5.0).

    Time frame: 3 years

Secondary outcomes

  1. Overall survival (OS)

    the time from randomization to documented death from any cause

    Time frame: 3 years

  2. Regional Relapse-free Survival(RRFS)

    the time from randomization to documented regional recurrence or death from any cause

    Time frame: 3 years

  3. Distant metastasis-free survival (DMFS)

    calculated from randomization to documented distant metastasis or death

    Time frame: 3 years

  4. Acute toxicities

    Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0

    Time frame: 3 months

  5. Late toxicities

    3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)

    Time frame: 3 years

  6. Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)

    Patient reported quality-of-life data and higher scores indicated more severe symptoms

    Time frame: 3 years

  7. Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)

    Patient reported quality-of-life data and higher scores indicated more severe symptoms

    Time frame: 3 years

  8. radiation-induced otitis media with effusion (OME)

    Evaluated by tympanometry

    Time frame: 3 years

  9. V60Gy

    Volume that received at least 60Gy

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

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

Started Aug 2023 (actual). Primary completion is estimated for Aug 2026, 36 months after the start.

Of 49 interventional studies with no phase under Nasopharyngeal Carcinoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22. This study's planned 36 months is below that.

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

Registered
Jul 25, 2023
First posted
Aug 16, 2023
StartActual
Aug 4, 2023
Primary completionEst.
Aug 4, 2026
CompletionEst.
Sep 1, 2029
Last update
Aug 16, 2023
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 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05994170
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborators
Sun Yat-sen University Cancer Centre
Responsible party
Gui-Qiong Xu (Clinical Professor, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Aug 16, 2023
Start date
Aug 4, 2023
Primary completion
Aug 4, 2026 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Aug 16, 2023

Study contacts

Gui-qiong Xu
Contact
donna_shee@163.com
+8613528109888
Gui-qiong Xu
principal investigator · Zhongshan People's Hospital, Guangdong, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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