Back to resultsReduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma, Radiotherapy; Complications
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Intensity Modulated Radiation Therapy
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria: Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III); All genders, range from 18-70 years old; ECOG score 0-1; Clinical stage I-IVa (AJCC/UICC 8th); Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); No contraindications to chemotherapy or radiotherapy; Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); Sign the consent form. Exclusion Criteria: Neck lymph nodes exist skipping metastasis; Distant metastases; Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; Have or are suffering from other malignant tumors; Participating in other clinical trials; Pregnancy or lactation; Have uncontrolled cardiovascular disease; Severe complication, eg, uncontrolled hypertension; Mental disorder; Drug or alcohol addition; Do not have full capacity for civil acts.
Sites / Locations
- Chongqing Cancer Hospital
- Dongguan People Hospital
- Sun Yat-sen University Cancer Center
- Liuzhou Worker's Hospital
- The First Affiliated Hospital of Guangxi Medical University
- Jiangxi Cancer Hospital of Nanchang University
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reduced CTVn2
Conventional CTVn2
Arm Description
Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Outcomes
Primary Outcome Measures
Regional recurrence-free survival
From the date of randomization to regional recurrence or any death
Secondary Outcome Measures
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Local recurrence-free survival
From the date of randomization to local recurrence or any death
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Acute toxicities
Assessed with CTCAE v5.0
Late toxicities
Assessed with RTOG/EORTC
Quality of life score
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Full Information
NCT ID
NCT05780372
First Posted
March 8, 2023
Last Updated
July 26, 2023
Sponsor
Sun Yat-sen University
Collaborators
Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Dongguan People's Hospital, LiuZhou People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05780372
Brief Title
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
Official Title
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Dongguan People's Hospital, LiuZhou People's Hospital
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
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Radiotherapy; Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reduced CTVn2
Arm Type
Experimental
Arm Description
Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
Arm Title
Conventional CTVn2
Arm Type
Active Comparator
Arm Description
Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Other Intervention Name(s)
IMRT
Intervention Description
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
Primary Outcome Measure Information:
Title
Regional recurrence-free survival
Description
From the date of randomization to regional recurrence or any death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Time Frame
3 years
Title
Local recurrence-free survival
Description
From the date of randomization to local recurrence or any death
Time Frame
3 years
Title
Distant metastasis-free survival
Description
From the date of randomization to distant metastasis or any death
Time Frame
3 years
Title
Progression free survival
Description
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time Frame
3 years
Title
Acute toxicities
Description
Assessed with CTCAE v5.0
Time Frame
From the start of treatment until 3 months post treatment
Title
Late toxicities
Description
Assessed with RTOG/EORTC
Time Frame
3 years post treatment
Title
Quality of life score
Description
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Time Frame
During treatment and 3 years post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
All genders, range from 18-70 years old;
ECOG score 0-1;
Clinical stage I-IVa (AJCC/UICC 8th);
Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
No contraindications to chemotherapy or radiotherapy;
Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
Sign the consent form.
Exclusion Criteria:
Neck lymph nodes exist skipping metastasis;
Distant metastases;
Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
Have or are suffering from other malignant tumors;
Participating in other clinical trials;
Pregnancy or lactation;
Have uncontrolled cardiovascular disease;
Severe complication, eg, uncontrolled hypertension;
Mental disorder;
Drug or alcohol addition;
Do not have full capacity for civil acts.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Zhao, MD PhD
Phone
02087342638
Email
zhaochong@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Miao, MD
Phone
+8613631355201
Email
miaojj@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Zhao, MD PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang, MD
Facility Name
Dongguan People Hospital
City
Dongguan
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Liu, MD, PhD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chong Zhao, MD, PhD
Email
zhaochong@sysucc.org.cn
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lu, MD
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Jiangxi Cancer Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingao Li, MD, PhD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.sysucc.org.cn
Description
Home Page of Cancer Center, Sun Yat-sen University
Learn more about this trial
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
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