ClinicalTrials.gg
RecruitingNCT06282497Updated May 1, 2024

Xerostomia-optimised IMRT Versus Standard IMRT in NPC

An interventional study of Optimised neck CTV and standard neck CTV in Nasopharyngeal Carcinoma ,Xerostomia,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 2024-05-01.

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

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2023, registered Feb 2024).
  • Started Oct 2023; still recruiting 3 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
524
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
25th of 417
524 · median 126
Started
2023
with 43 others
No phase
54 of 489
25 open now
Primary completion
2026-10
later than 127 of 253 live
Registered
382nd of 489
by date

Among the 489 studies in Nasopharyngeal Carcinoma with a site in China, this one is the 25th 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 127 of the 253 other live ones, and was the 382nd 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

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients

Read the detailed description

Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.

03

Conditions studied

  • Nasopharyngeal Carcinoma ,Xerostomia,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

  • Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
  • All genders, range from 18-70 years old;
  • score 0-1;
  • Clinical stage I-IVa (AJCC/UICC 8th);
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
  • No to chemotherapy or radiotherapy;
  • Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, ≥ 90g/L, count ≥ 100×109/L; or aspartate aminotransferase \< 2.5×; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous ≥ 60ml/min (Cockcroft-Gault formula);
  • Sign the consent form.

Exclusion criteria

Exclusion Criteria:

  • Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;

    -≥4 nodal regions of ipsilateral neck involvement;

  • Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
  • Parotid lymph node and/or parotid gland involvement;
  • History of parotid disease or surgery;
  • Previous or other concomitant malignant disease;
  • Pregnancy or lactation.
Terms in these criteria, in plain language(8)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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).

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
524 participants (estimated)

Study arms

  • Experimental
    Study Group

    optimised neck CTV delineation

    Radiation: Optimised neck CTV

  • Active comparator
    Control Group

    standard neck CTV delineation

    Radiation: standard neck CTV

Interventions

  • RadiationOptimised neck CTV

    neck CTV delineation extends from the lateral process of C1

  • Radiationstandard neck CTV

    neck CTV delineation extends from skull base

06

What researchers measure

Primary outcomes

  1. Regional recurrence free survival

    From the date of randomization to regional recurrence or any death

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up

    Time frame: 3 years

  2. Local recurrence free survival

    From the date of randomization to local recurrence or any death

    Time frame: 3 years

  3. Distant metastasis-free survival

    From the date of randomization to distant metastasis or any death

    Time frame: 3 years

  4. Progression free survival

    From the date of randomization to local or regional recurrence, distant metastasis or any death

    Time frame: 3 years

  5. Acute toxicities

    Assessed with CTCAE v5.0

    Time frame: From the start of treatment until 3 months post treatment

  6. Late toxicities

    Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0

    Time frame: 3 years post treatment

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 Oct 2023 (actual). Primary completion is estimated for Oct 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
Feb 21, 2024
First posted
Feb 28, 2024
StartActual
Oct 23, 2023
Primary completionEst.
Oct 23, 2026
CompletionEst.
Oct 23, 2029
Last update
May 1, 2024
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 May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06282497
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Responsible party
Gui-Qiong Xu (Chief Physician, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Feb 28, 2024
Start date
Oct 23, 2023
Primary completion
Oct 23, 2026 (estimated)
Completion
Oct 23, 2029 (estimated)
Last update
May 1, 2024

Study contacts

Gui-qiong Xu, MD
Contact
donna_shee@163.com
+8613528109888
Gui-qiong Xu, MD
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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