Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06516133

Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

Led by Sun Yat-sen University · Updated on 2024-07-23

494

Participants Needed

1

Research Sites

341 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.

CONDITIONS

Official Title

Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with non-keratinizing carcinoma type
  • No evidence of distant metastasis (M0)
  • Age between 18 and 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Undergoing radical intensity-modulated radiation therapy (IMRT)
  • No claustrophobia and able to remain in a fixed position for at least 30 minutes
  • Informed consent signed and willing to comply with treatment, follow-up, and tests as per protocol
Not Eligible

You will not qualify if you...

  • Histological types of squamous cell carcinoma or basal cell carcinoma
  • Radiotherapy intended only for palliative care
  • History of malignant tumors except adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia
  • Pregnant or lactating women; women of childbearing age must undergo pregnancy testing and use effective contraception during treatment
  • Previous radical radiotherapy for nasopharyngeal cancer
  • Primary and neck metastatic lesions previously treated with chemotherapy or surgery
  • Serious underlying diseases affecting safety or compliance, such as unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes, or psychiatric disorders
  • Initial treatment efficacy assessment more than 120 days after radiotherapy
  • Inability to undergo enhanced MRI due to contrast allergy or claustrophobia

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

Y

Yu-xian Yang, MD

CONTACT

G

Guan-qun Zhou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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