Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304468
• Other study ID #: 2022-FXY-017
• Status: Recruiting
• Phase: Phase 3
• Start date: March 29, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2023
• Source: Sun Yat-sen University
• Contact: Hai Qiang Mai, Dr
• Phone: 020-87343380
• Email: maihq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• IMRT
Patients in experimental group received reduced dose IMRT

Drug:
• induction chemotherapy
cisplatin-based induction chemotherapy for two cycles
• cisplatin concurrent chemotherapy
cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Locations

Country	Name	City	State
China	Sun Yat-sen Universitty Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (progression-free survival)	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.	2 year
Secondary	Overall Survival(OS)	Defined as the time from randomization to death from any cause	2 year
Secondary	Locoregional relapse-free survival(LRFS)	Defined as the time from randomization to the first local or regional recurrence, or death from any cause.; follow-up visit.	2 year
Secondary	Distant metastasis-free survival(DMFS)	Defined as the time from randomization to the first distant metastasis or death from any cause.	2 year
Secondary	Overall response rate	Tumour response rate was classified according to RECIST, version 1.1	3 months
Secondary	Incidence rate of adverse events (AEs)	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.	2 year
Secondary	Change of QoL	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	1 year
Secondary	Change of EORTC quality of life questionnaire(QLQ) Head and Neck score	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	1 year