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Not yet recruiting NCT04215510

Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Phase III Interventional Recurrent Nasopharyngeal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endonasal endoscopic surgery, radiation therapy(IMRT).
Who it may be relevant to
Registry conditions: Recurrent Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure endonasal endoscopic surgery
    143 patients will undergo endonasal endoscopic surgery
  • Radiation radiation therapy(IMRT)
    143 patients will undergo radiation therapy.

Primary outcome measures

  • 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.]
Secondary outcome measures (5)
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • toxicities [Time frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Fujian Medical University Union Hospital — Fuzhou
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Fudan University Shanghai cancer center — Shanghai

Identifiers

NCT: NCT04215510 · early-rNPC-RCT-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗