Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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