Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05994170

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

Led by Zhongshan People's Hospital, Guangdong, China · Updated on 2023-08-16

454

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

Sponsors

Z

Zhongshan People's Hospital, Guangdong, China

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic confirmation of nonkeratinizing nasopharyngeal carcinoma (WHO II-III)
  • Newly diagnosed stage I to IVa nasopharyngeal carcinoma
  • Tumor confined to one side of the nasopharynx and not crossing the midline confirmed by nasopharyngoscope and MRI
  • Planned to receive curative intensity-modulated radiotherapy (IMRT) with chemotherapy according to guidelines
  • No previous cancer treatment
  • Karnofsky performance status score of at least 70
  • Age between 18 and 70 years
  • Adequate blood, liver, and kidney function
  • Provided written informed consent after being informed about the study
Not Eligible

You will not qualify if you...

  • Treatment given with palliative intent
  • Previous radiotherapy, chemotherapy, or surgery to the nasopharynx (except diagnostic procedures)
  • Disease progression after neoadjuvant chemotherapy in locally advanced nasopharyngeal carcinoma
  • Presence of distant metastasis
  • Keratinized squamous cell carcinoma or basal cell-like squamous cell carcinoma
  • Prior malignancy except treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma
  • New York Heart Association class 3 or 4 heart failure, unstable angina, recent myocardial infarction, or clinically significant arrhythmia requiring treatment
  • Pregnancy or lactation
  • Mental disorders, drug or alcohol addiction, or lack of full legal capacity to consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhongshan City People's Hospital

Zhongshan, Guangdong, China, 528403

Actively Recruiting

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Research Team

G

Gui-qiong Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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