Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University
About this trial
This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.
Eligibility criteria
Qualifiers
Age: 18 Years to 65 Years.
Eastern Cooperative Oncology Group performance status ≤1.
Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype).
Tumor staged as T1-4N0-3M0 (AJCC 9th).
Disqualifiers
Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis > 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.
Active infection requiring systemic treatment.
Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer.
History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma.
Trial design
Treatments tested in this trial
- Comprehensive Therapy Based on Tumor Stage
- IMRT with Primary Clinical Target Volume Based on Margin Expansion
- IMRT with Consensus Primary Clinical Target Volume
Treatment groups
568 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov