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Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Primary Purpose

Recurrent Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
endonasal endoscopic surgery
radiation therapy(IMRT)
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma focused on measuring endonasal endoscopic surgery, radiation therapy, nasopharyngeal carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
  2. Stage T1 or T2 according to AJCC 8th edition ;
  3. Aged 18 to 70 years;
  4. Without metastasis;
  5. previously received 1 course of radiotherapy;
  6. Without radiotherapy within 1 year, without local treatment for recurrent disease;
  7. Surgical resectable and IMRT suitable;
  8. If regional recurrence presented, regional lesion can be treated with local treatments.
  9. ECOG score 0 or 1;
  10. Sufficient organ function;
  11. Acceptable approach of contraception.

Exclusion Criteria:

  1. Refuse to sign inform consent;
  2. Radiation encephalopathy or leptomeningeal disease (LMD);
  3. History of radioactive particle planting;
  4. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
  5. With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
  6. Any contradiction to surgery;
  7. Have any co-existing condition that would preclude full compliance or safety with the study;
  8. Presence of a significant neurological or psychiatric disease, including dementia and seizures;
  9. Uncontrolled infectious diseases;
  10. Female patients who are at pregnancy or lactation.
  11. Without personal freedom or independent civil capacity.
  12. With serious autoimmune disease.
  13. Participants of other interventional clinical trial.

Sites / Locations

  • Fujian Medical University Union Hospital
  • The First Affiliated Hospital of Nanchang University
  • Fudan University Shanghai cancer center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endonasal endoscopic surgery group

radiation therapy group

Arm Description

143 participants in group 1 will undergo endoscopic surgery

143 participants in group 2 will undergo radiation therapy(IMRT)

Outcomes

Primary Outcome Measures

3 year Overall Survival (OS) rate
The proportion of patients who survived 3 years

Secondary Outcome Measures

progression free survival(PFS)
the time from randomization to the first recording of disease progression or death from any cause.
Local progression free survival(LPFS)
the time from randomization to local failure or death
Regional progression free survival(RPFS)
From randomization to regional failure or death
Distant metastasis free survival(DMFS)
From randomization to distant metastasis or death
toxicities
Using CTCAE Version5.0 to evaluate

Full Information

First Posted
December 2, 2019
Last Updated
February 20, 2021
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences, Shanghai Municipal Science and Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04215510
Brief Title
Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
Official Title
A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences, Shanghai Municipal Science and Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Detailed Description
Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Nasopharyngeal Carcinoma
Keywords
endonasal endoscopic surgery, radiation therapy, nasopharyngeal carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endonasal endoscopic surgery group
Arm Type
Experimental
Arm Description
143 participants in group 1 will undergo endoscopic surgery
Arm Title
radiation therapy group
Arm Type
Active Comparator
Arm Description
143 participants in group 2 will undergo radiation therapy(IMRT)
Intervention Type
Procedure
Intervention Name(s)
endonasal endoscopic surgery
Intervention Description
143 patients will undergo endonasal endoscopic surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy(IMRT)
Intervention Description
143 patients will undergo radiation therapy.
Primary Outcome Measure Information:
Title
3 year Overall Survival (OS) rate
Description
The proportion of patients who survived 3 years
Time Frame
From date of randomization until the date of death from any cause,through study completion,up to 3 years.
Secondary Outcome Measure Information:
Title
progression free survival(PFS)
Description
the time from randomization to the first recording of disease progression or death from any cause.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years.
Title
Local progression free survival(LPFS)
Description
the time from randomization to local failure or death
Time Frame
From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Title
Regional progression free survival(RPFS)
Description
From randomization to regional failure or death
Time Frame
From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Title
Distant metastasis free survival(DMFS)
Description
From randomization to distant metastasis or death
Time Frame
From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
Title
toxicities
Description
Using CTCAE Version5.0 to evaluate
Time Frame
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Other Pre-specified Outcome Measures:
Title
quality of life(QoL): EORTC QLQ - H&N35 questionaire
Description
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems.
Time Frame
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Title
quality of life(QoL): EORTC QLQ - C30 questionaire
Description
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time Frame
From date of randomization until 3 years after randomization,through study completion,up to 3 years.

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: Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study; Stage T1 or T2 according to AJCC 8th edition ; Aged 18 to 70 years; Without metastasis; previously received 1 course of radiotherapy; Without radiotherapy within 1 year, without local treatment for recurrent disease; Surgical resectable and IMRT suitable; If regional recurrence presented, regional lesion can be treated with local treatments. ECOG score 0 or 1; Sufficient organ function; Acceptable approach of contraception. Exclusion Criteria: Refuse to sign inform consent; Radiation encephalopathy or leptomeningeal disease (LMD); History of radioactive particle planting; Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy; With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer ); Any contradiction to surgery; Have any co-existing condition that would preclude full compliance or safety with the study; Presence of a significant neurological or psychiatric disease, including dementia and seizures; Uncontrolled infectious diseases; Female patients who are at pregnancy or lactation. Without personal freedom or independent civil capacity. With serious autoimmune disease. Participants of other interventional clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaole Song, MD
Phone
+86 15821388769
Email
jxfxsxl@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihui Pang
Phone
+86 18818211894
Email
pangzhihui1229@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmeng Yu, MD
Organizational Affiliation
Eye&ENT Hospital,Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desheng Wang, MD
First Name & Middle Initial & Last Name & Degree
Haichun Lai, MD
First Name & Middle Initial & Last Name & Degree
Desheng Wang
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ye, MD
First Name & Middle Initial & Last Name & Degree
Jing Ye
Facility Name
Fudan University Shanghai cancer center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
First Name & Middle Initial & Last Name & Degree
Jiyi Hu, MD
First Name & Middle Initial & Last Name & Degree
Lin Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

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