Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
1 other identifier
interventional
286
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
Longer than P75 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 23, 2021
February 1, 2021
6 years
December 2, 2019
February 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3 year Overall Survival (OS) rate
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 Outcomes (5)
progression free survival(PFS)
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)
From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Regional progression free survival(RPFS)
From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Distant metastasis free survival(DMFS)
From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
toxicities
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Other Outcomes (2)
quality of life(QoL): EORTC QLQ - H&N35 questionaire
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
quality of life(QoL): EORTC QLQ - C30 questionaire
From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Study Arms (2)
endonasal endoscopic surgery group
EXPERIMENTAL143 participants in group 1 will undergo endoscopic surgery
radiation therapy group
ACTIVE COMPARATOR143 participants in group 2 will undergo radiation therapy(IMRT)
Interventions
143 patients will undergo endonasal endoscopic surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongmeng Yu, MD
Eye&ENT Hospital,Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
December 2, 2019
First Posted
January 2, 2020
Study Start
March 1, 2021
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share