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Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

Primary Purpose

Toxicity Due to Radiotherapy, Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Target range
Sponsored by
First Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxicity Due to Radiotherapy focused on measuring Reduced target, Nasopharyngeal Carcinoma, Radiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III). The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage). Patients who have not received radiation therapy before. After induction chemotherapy, CR or PR were evaluated by radiography. Age 18-65 years old. ECOG score of 0-1. Good organ function The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs. Exclusion Criteria: Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded. Patients with relapsed and distant metastases. The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain). Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx. Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3). Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment. Those who have participated in clinical trials of other drugs within 3 months before treatment. Pregnant or lactating women. Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

Sites / Locations

  • First Affiliated Hospital of Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced target radiotherapy

Arm Description

According to our institutional guidelines, GTVnx included the primary tumor volume and the enlarged retropharyngeal nodes, while GTVnd was the volume of involved gross cervical lymph nodes. The clinical tumor volume (CTV) includes the primary tumor with potential subclinical disease. The high-risk clinical target volume (CTV1) was defined as the GTVnx plus a 5-mm margin to encompass the high-risk sites of microscopic extension, the whole nasopharynx, retropharyngeal nodal regions and . The low-risk clinical target volume (CTV2) was defined as the whole neck area.(Ib, VIIb, and the commom carotid artery are not included).

Outcomes

Primary Outcome Measures

Regional recurrence-free survival
The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 1 years.

Secondary Outcome Measures

Overall survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Distant metastasis-free survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Progress Free Survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Acute radiation toxicity
The injuries after the beginning of radiotherapy include skin, mucosa, pharynx and esophagus, eyes, ears, nervous system, blood system and other organs and tissues，assessed up to 3 months.

Full Information

First Posted
February 11, 2023
Last Updated
February 14, 2023
Sponsor
First Affiliated Hospital of Kunming Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05741008
Brief Title
Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma
Official Title
Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Kunming Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxicity Due to Radiotherapy, Nasopharyngeal Carcinoma
Keywords
Reduced target, Nasopharyngeal Carcinoma, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced target radiotherapy
Arm Type
Experimental
Arm Description
According to our institutional guidelines, GTVnx included the primary tumor volume and the enlarged retropharyngeal nodes, while GTVnd was the volume of involved gross cervical lymph nodes. The clinical tumor volume (CTV) includes the primary tumor with potential subclinical disease. The high-risk clinical target volume (CTV1) was defined as the GTVnx plus a 5-mm margin to encompass the high-risk sites of microscopic extension, the whole nasopharynx, retropharyngeal nodal regions and . The low-risk clinical target volume (CTV2) was defined as the whole neck area.(Ib, VIIb, and the commom carotid artery are not included).
Intervention Type
Radiation
Intervention Name(s)
Target range
Intervention Description
Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.
Primary Outcome Measure Information:
Title
Regional recurrence-free survival
Description
The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 1 years.
Time Frame
up to 1 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Time Frame
up to 1 years
Title
Distant metastasis-free survival
Description
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Time Frame
up to 1 years
Title
Progress Free Survival
Description
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Time Frame
up to 1 years
Title
Acute radiation toxicity
Description
The injuries after the beginning of radiotherapy include skin, mucosa, pharynx and esophagus, eyes, ears, nervous system, blood system and other organs and tissues，assessed up to 3 months.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III). The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage). Patients who have not received radiation therapy before. After induction chemotherapy, CR or PR were evaluated by radiography. Age 18-65 years old. ECOG score of 0-1. Good organ function The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs. Exclusion Criteria: Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded. Patients with relapsed and distant metastases. The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain). Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx. Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3). Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment. Those who have participated in clinical trials of other drugs within 3 months before treatment. Pregnant or lactating women. Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiqiang Wang, MD
Phone
15887085161
Email
wangzhiqiang@ydyy.cn
Facility Information:
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Wang, MD
Phone
15887085161
Email
wangzhiqiang@ydyy.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

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