Induction Chemotherapy, Nasopharyngeal Carcinoma, Radiotherapy
Conditions
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.
Interventions
RADIATIONDelineating the GTV according to the pretreatment or post-IC tumor extension
Delineating the GTV according to the pretreatment or post-IC tumor extension
Sponsors
First People's Hospital of Foshan
Cancer Research Institute of Zhongshan City
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multicentre, Non-inferiority, Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival (RFS) | 3 year | the time from randomization to documented locoregional recurrence or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicities | 3 months | Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria |
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) | 3 year | Patient-reported QoL |
| Overall survival (OS) | 3 year | the time from randomization to documented death from any cause |
| Distant metastasis-free survival (DMFS) | 3 year | DMFS was calculated from randomization to documented distant metastasis or death. |
| Acute toxicities | 3 months | Occur within 3 months after IMRT |
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) | 3 year | Patient-reported QoL |
Countries
China
Outcome results
None listed