Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

Phase 3

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: IMRT; Drug: induction chemotherapy; Drug: cisplatin concurrent chemotherapy

• Registration Number: NCT05304468
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

Detailed Description

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Study Start: 2022-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-10-29
• Study Completion: 2029-10-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
2. Stage II-III（8thAJCC/UICC staging system)
3. Aged 18-70 years
4. ECOG = 0-1
5. HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
6. ALT,AST<1.5 x ULN；TBIL<1.5×ULN
7. CCR≥60ml/min or Cr<1.5×ULN
8. CR/PR and EBVDNA undetectable after induction chemotherapy
9. Signed informed consent

Exclusion Criteria

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
2. Age <18 or >70years
3. Treatment with palliative intent
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
5. Pregnancy or lactation
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced-dose group	cisplatin concurrent chemotherapy	After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
Standard dose group	cisplatin concurrent chemotherapy	After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
Reduced-dose group	IMRT	After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
Standard dose group	induction chemotherapy	After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
Standard dose group	IMRT	After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
Reduced-dose group	induction chemotherapy	After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.

Primary Outcome Measures

Name	Time	Method
PFS (progression-free survival)	2 year	Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	2 year	Defined as the time from randomization to death from any cause
Locoregional relapse-free survival(LRFS)	2 year	Defined as the time from randomization to the first local or regional recurrence, or death from any cause.; follow-up visit.
Incidence rate of adverse events (AEs)	2 year	Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Distant metastasis-free survival(DMFS)	2 year	Defined as the time from randomization to the first distant metastasis or death from any cause.
Overall response rate	3 months	Tumour response rate was classified according to RECIST, version 1.1
Change of QoL	1 year	QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
Change of EORTC quality of life questionnaire(QLQ) Head and Neck score	1 year	QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H\&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva,coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.All of the scores mentioned above were assessed at the below time point:before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

Trial Locations

Locations (1)

Sun Yat-sen Universitty Cancer Center; 🇨🇳 Guangzhou, Guangdong, China