Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT05145660

Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Led by Jun-Lin Yi, MD · Updated on 2022-09-27

414

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

CONDITIONS

Official Title

Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Karnofsky performance status (KPS) score  70
  • Pathologically confirmed World Health Organization (WHO) type II-III nasopharyngeal carcinoma
  • TNM stage I-III (T1-3N0-2M0) with maximum involved lymph node diameter = 3 cm
  • Available baseline nasopharynx and neck CT or MRI scans with measurable tumor lesions
  • Tumor burden assessment completed within 4 weeks before registration
  • Survival expectancy of at least 6 months
  • Normal marrow and organ function (hemoglobin  120 g/L, WBCs  4 �d7 10^9/L, platelets  100 �d7 10^9/L, liver and kidney function within 1.25 times normal upper limit)
  • Willingness to comply with the study protocol
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, China, 100021

Actively Recruiting

Loading map...

Research Team

J

Junlin Yi, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Optimization of Cervical Nodal CTV for Early and Medium Stage NPC | DecenTrialz