Status:
ACTIVE_NOT_RECRUITING
Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First People's Hospital of Foshan
Cancer Research Institute of Zhongshan City
Conditions:
Nasopharyngeal Carcinoma
Induction Chemotherapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma pati...
Detailed Description
This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction...
Eligibility Criteria
Inclusion
- histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage III to IVa disease that was staged according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of Induction Chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function.
Exclusion
- younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after IC
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT04384627
Start Date
December 1 2019
End Date
October 1 2026
Last Update
September 4 2025
Active Locations (2)
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1
First People's Hospital of Foshan, Foshan
Foshan, China
2
People's Hospital of Zhongshan City
Zhongshan, China