Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy
- Conditions
- RadiotherapyNasopharyngeal CarcinomaInduction Chemotherapy
- Interventions
- Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension
- Registration Number
- NCT04384627
- Lead Sponsor
- Sun Yat-sen University
- 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 patients treated with induction chemotherapy plus concurrent chemoradiotherapy.
- 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 chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 445
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Post-IC GTV Delineating the GTV according to the pretreatment or post-IC tumor extension The gross tumor volume (GTV) is delineated according to the post-IC tumor extension Pre-IC GTV Delineating the GTV according to the pretreatment or post-IC tumor extension The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) 3 year the time from randomization to documented locoregional recurrence or death from any cause
- Secondary Outcome Measures
Name Time Method Acute toxicities 3 months Occur within 3 months after IMRT
Overall survival (OS) 3 year the time from randomization to documented death from any cause
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) 3 year Patient-reported QoL
Late toxicities 3 months Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria
Distant metastasis-free survival (DMFS) 3 year DMFS was calculated from randomization to documented distant metastasis or death.
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) 3 year Patient-reported QoL
Trial Locations
- Locations (2)
First People's Hospital of Foshan, Foshan
🇨🇳Foshan, China
People's Hospital of Zhongshan City
🇨🇳Zhongshan, China