Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

February 20, 2021 updated by: Hongmeng Yu, Eye & ENT Hospital of Fudan University

A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaole Song, MD
  • Phone Number: +86 15821388769
  • Email: jxfxsxl@163.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
        • Contact:
          • Desheng Wang, MD
        • Contact:
          • Haichun Lai, MD
        • Principal Investigator:
          • Desheng Wang
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Jing Ye, MD
        • Principal Investigator:
          • Jing Ye
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Lin Kong, MD
        • Contact:
          • Jiyi Hu, MD
        • Principal Investigator:
          • Lin Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endonasal endoscopic surgery group
143 participants in group 1 will undergo endoscopic surgery
Procedure: endonasal endoscopic surgery
143 patients will undergo endonasal endoscopic surgery
Active Comparator: radiation therapy group
143 participants in group 2 will undergo radiation therapy(IMRT)
Radiation: radiation therapy(IMRT)
143 patients will undergo radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 year Overall Survival (OS) rate
Time Frame: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
The proportion of patients who survived 3 years
From date of randomization until the date of death from any cause,through study completion,up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival(PFS)
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.
the time from randomization to the first recording of disease progression or death from any cause.
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.
Local progression free survival(LPFS)
Time Frame: From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
the time from randomization to local failure or death
From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Regional progression free survival(RPFS)
Time Frame: From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
From randomization to regional failure or death
From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Distant metastasis free survival(DMFS)
Time Frame: From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
From randomization to distant metastasis or death
From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
toxicities
Time Frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Using CTCAE Version5.0 to evaluate
From date of randomization until 3 years after randomization,through study completion,up to 3 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life(QoL): EORTC QLQ - H&N35 questionaire
Time Frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
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.
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
quality of life(QoL): EORTC QLQ - C30 questionaire
Time Frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
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.
From date of randomization until 3 years after randomization,through study completion,up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Shanghai Municipal Science and Technology Commission

Investigators

  • Principal Investigator: Hongmeng Yu, MD, Eye&ENT Hospital,Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2027

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 20, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • early-rNPC-RCT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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