Clinical trial NCT02642107: Individualized Elective Neck Irradiation Based on MRI in NPC Patients
Official title: The Multicenter Randomized Phase 3 Trial of Individualized Elective Neck Irradiation Based on MRI in Patients With Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
elective neck irradiation
upper neck irradiation
whole neck irradiation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Foshan
name: Guilin Medical College
First posted: 2015-12-30
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Detailed description: Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Eligibility criteria: The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; Karnofsky performance-status score \> 70; adequate haematological function, with a leucocyte count \> 4 × 109/L, haemoglobin \> 90 g/L, and a thrombocyte count \> 100×109/L.

The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.

Primary outcomes:
measure: Regional relapse-free survival
timeFrame: 3 year
Secondary outcomes:
measure: Radiation-related toxicity
timeFrame: Within 1 month after radiotherapy for acute toxicity; long term for late toxicity
measure: Overall survival
timeFrame: 3 year
measure: Local relapse-free survival
timeFrame: 3 year
measure: Distant metastasis-free survival
timeFrame: 3 year
measure: Patient's quality-of-life: global health status
timeFrame: 3 year
measure: Patient's quality-of-life: physical functioning
timeFrame: 3 year
measure: Patient's quality-of-life: role functioning
timeFrame: 3 year
measure: Patient's quality-of-life: emotional functioning
timeFrame: 3 year
measure: Patient's quality-of-life: cognitive functioning
timeFrame: 3 year
measure: Patient's quality-of-life: social functioning
timeFrame: 3 year
measure: Patient's quality-of-life: fatigue
timeFrame: 3 year
measure: Patient's quality-of-life: nausea and vomiting
timeFrame: 3 year
measure: Patient's quality-of-life: pain
timeFrame: 3 year
measure: Patient's quality-of-life: dyspnoea
timeFrame: 3 year
measure: Patient's quality-of-life: insomnia
timeFrame: 3 year
measure: Patient's quality-of-life: appetite loss
timeFrame: 3 year
measure: Patient's quality-of-life: constipation
timeFrame: 3 year
measure: Patient's quality-of-life: diarrhoea
timeFrame: 3 year
measure: Patient's quality-of-life: financial difficulties
timeFrame: 3 year
measure: Patient's quality-of-life: pain
timeFrame: 3 year
measure: Patient's quality-of-life: swallowing
timeFrame: 3 year
measure: Patient's quality-of-life: sense problems
timeFrame: 3 year
measure: Patient's quality-of-life: speech problems
timeFrame: 3 year
measure: Patient's quality-of-life: trouble social eating
timeFrame: 3 year
measure: Patient's quality-of-life: trouble social contact
timeFrame: 3 year
measure: Patient's quality-of-life: less sexuality
timeFrame: 3 year
measure: Patient's quality-of-life: teeth
timeFrame: 3 year
measure: Patient's quality-of-life: open mouth
timeFrame: 3 year
measure: Patient's quality-of-life: dry mouth
timeFrame: 3 year
measure: Patient's quality-of-life: sticky saliva
timeFrame: 3 year
measure: Patient's quality-of-life: coughing
timeFrame: 3 year
measure: Patient's quality-of-life: felt ill
timeFrame: 3 year
measure: Patient's quality-of-life: pain killers
timeFrame: 3 year
measure: Patient's quality-of-life: nutrition supplement
timeFrame: 3 year
measure: Patient's quality-of-life: feeding tube
timeFrame: 3 year
measure: Patient's quality-of-life: weight loss
timeFrame: 3 year
measure: Patient's quality-of-life: weight gain
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun sat-sen University Cancer Center
name: Linglong Tang, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang LL, Huang CL, Zhang N, Jiang W, Wu YS, Huang SH, Mao YP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Sun Y, Xie FY, Chen L, Zhou GQ, Ma J. Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial. Lancet Oncol. 2022 Apr;23(4):479-490. doi: 10.1016/S1470-2045(22)00058-4. Epub 2022 Feb 28.