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Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IMRT
induction chemotherapy
cisplatin concurrent chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, radiotherapy, induction chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen Universitty Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced-dose group

Standard dose group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival(OS)
Defined as the time from randomization to death from any cause
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.
Distant metastasis-free survival(DMFS)
Defined as the time from randomization to the first distant metastasis or death from any cause.
Overall response rate
Tumour response rate was classified according to RECIST, version 1.1
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.
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
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

Full Information

First Posted
March 28, 2022
Last Updated
January 18, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05304468
Brief Title
Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, radiotherapy, induction chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
phase III non-inferiority
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced-dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard dose group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
Patients in experimental group received reduced dose IMRT
Intervention Type
Drug
Intervention Name(s)
induction chemotherapy
Intervention Description
cisplatin-based induction chemotherapy for two cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin concurrent chemotherapy
Intervention Description
cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)
Primary Outcome Measure Information:
Title
PFS (progression-free survival)
Description
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Description
Defined as the time from randomization to death from any cause
Time Frame
2 year
Title
Locoregional relapse-free survival(LRFS)
Description
Defined as the time from randomization to the first local or regional recurrence, or death from any cause. follow-up visit.
Time Frame
2 year
Title
Distant metastasis-free survival(DMFS)
Description
Defined as the time from randomization to the first distant metastasis or death from any cause.
Time Frame
2 year
Title
Overall response rate
Description
Tumour response rate was classified according to RECIST, version 1.1
Time Frame
3 months
Title
Incidence rate of adverse events (AEs)
Description
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.
Time Frame
2 year
Title
Change of QoL
Description
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
Time Frame
1 year
Title
Change of EORTC quality of life questionnaire(QLQ) Head and Neck score
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III). Stage II-III（8thAJCC/UICC staging system) Aged 18-70 years ECOG = 0-1 HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L ALT,AST<1.5 x ULN；TBIL<1.5×ULN CCR≥60ml/min or Cr<1.5×ULN CR/PR and EBVDNA undetectable after induction chemotherapy Signed informed consent Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Age <18 or >70years Treatment with palliative intent Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer Pregnancy or lactation History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume) Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hai Qiang Mai, Dr
Phone
020-87343380
Email
maihq@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai Qiang Mai, Dr
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen Universitty Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai-Qiang Mai, MD,PhD
Phone
+862087343643
Email
maihq@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Hai-Qiang Mai, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

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