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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

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

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.

02

Conditions studied

  • Nasopharyngeal Carcinoma
  • Intensity-Modulated Radiotherapy
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 biopsy 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 neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
  5. no previous treatment for cancer;
  6. a Karnofsky 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, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  9. Patients must be informed of the investigational nature of this study and give written informed consent.

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 neoadjuvant chemotherapy in local advantage NPC
  4. presence of distant metastasis;
  5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
  6. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
  7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful 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.
04

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)

05

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

06

Study locations

1 of 1 sites recruiting
  • Zhongshan City People's Hospital
    Zhongshan, Guangdong 528403, China
    Recruiting
07

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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