Clinical trial NCT05994170: Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma
Official title: Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Intensity-Modulated Radiotherapy
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University Cancer Centre
First posted: 2023-08-16
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.

Detailed description: This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.

Eligibility criteria: Inclusion Criteria:

1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
2. newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
3. nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
4. planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA\>4000 copies，node \>3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
5. no previous treatment for cancer；
6. a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
7. between 18 and 70 years old;
8. adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. receipt of treatment with palliative intent;
2. receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx;
3. had disease progress after neoadjuvant chemotherapy in local advantage NPC
4. presence of distant metastasis;
5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
6. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
8. lactation or pregnancy;
9. Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

Primary outcomes:
measure: Local Relapse-free Survival(LRFS)
timeFrame: 3 years
measure: Incidence of hearing impairment worse than graded 2
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Regional Relapse-free Survival(RRFS)
timeFrame: 3 years
measure: Distant metastasis-free survival (DMFS)
timeFrame: 3 years
measure: Acute toxicities
timeFrame: 3 months
measure: Late toxicities
timeFrame: 3 years
measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
timeFrame: 3 years
measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
timeFrame: 3 years
measure: radiation-induced otitis media with effusion (OME)
timeFrame: 3 years
measure: V60Gy
timeFrame: 3 years
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
Study officials:
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Gui-qiong Xu
role: PRINCIPAL_INVESTIGATOR
References: