Clinical trial NCT04384627: Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy
Official title: Reducing Target Volumes in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy: A Phase 3, Multicentre, Non-inferiority, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Induction Chemotherapy
Radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Foshan
name: Cancer Research Institute of Zhongshan City
First posted: 2020-05-12
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, Non-inferiority, Randomised controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: 3 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 year
measure: Late toxicities
timeFrame: 3 months
measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
timeFrame: 3 year
measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
timeFrame: 3 year
measure: Distant metastasis-free survival (DMFS)
timeFrame: 3 year
measure: Acute toxicities
timeFrame: 3 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: First People's Hospital of Foshan, Foshan
city: Zhongshan
country: China
facility: People's Hospital of Zhongshan City
Study officials:
affiliation: Sun Yat-sen University Cancer Centr
name: Ling-Long Tang
role: PRINCIPAL_INVESTIGATOR
References:
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