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Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • endonasal endoscopic surgery

    Procedure/Surgery

    143 patients will undergo endonasal endoscopic surgery

  • radiation therapy(IMRT)

    Radiation

    143 patients will undergo radiation therapy.

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: endonasal endoscopic surgery groupExperimental treatment 1 intervention
Group B: radiation therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3 year Overall Survival (OS) rate

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 outcomes

1

progression free survival(PFS)

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.
2

Local progression free survival(LPFS)

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.
3

Regional progression free survival(RPFS)

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.
4

Distant metastasis free survival(DMFS)

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.

Other outcomes

1

quality of life(QoL): EORTC QLQ - H&N35 questionaire

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.
2

quality of life(QoL): EORTC QLQ - C30 questionaire

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator

Shanghai Municipal Science and Technology Commission

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: