Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04215510
• Other study ID #: early-rNPC-RCT-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: March 1, 2027

Study information

• Verified date: February 2021
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: +86 15821388769
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 286
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrent Nasopharyngeal Carcinoma

Intervention

Procedure:
• endonasal endoscopic surgery
143 patients will undergo endonasal endoscopic surgery

Radiation:
• radiation therapy(IMRT)
143 patients will undergo radiation therapy.

Locations

Country	Name	City	State
China	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

Sponsors (3)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Chinese Academy of Medical Sciences, Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Other	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.	From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Primary	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	progression free survival(PFS)	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.
Secondary	Local progression free survival(LPFS)	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.
Secondary	Regional progression free survival(RPFS)	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.
Secondary	Distant metastasis free survival(DMFS)	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.
Secondary	toxicities	Using CTCAE Version5.0 to evaluate	From date of randomization until 3 years after randomization,through study completion,up to 3 years.