Back to resultsOptimization of Cervical Nodal CTV for Early and Medium Stage NPC
Primary Purpose
Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
intensity-modulated radiotherapy (IMRT) with reduced-volume
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
- Age between 18 and 75 years;
- Karnofsky performance status (KPS) score ≥ 70;
- Pathologically confirmed World Health Organization (WHO) type II-III NPC;
- TNM stage I-III (T1-3N0-2M0) according to the 8th American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) staging system with a maximum diameter (MAD) of cervical involved LNs ≤ 3 cm, namely LB-LN;
- Available baseline nasopharynx and neck computed tomography (CT) or magnetic resonance imaging (MRI) (strongly advocated) data (including functional MRI sequences) and measurable tumor lesions;
- All procedures for defining the tumor burden completed within 4 weeks of registration;
- Survival expectancy of at least 6 months;
- Normal marrow and organ function: hemoglobin ≥ 120 g/L, WBCs ≥ 4 × 109 /L, platelets ≥ 100 × 109 /L; liver and kidney function-related indicators within 1.25*the normal upper limit;
- Patient willingness to comply with the protocol;
- Patient willingness and ability to provide an informed consent form.
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Involved site irradiation
Elective region irradiation
Arm Description
High-risk CTV1 : GTVnx plus a 10-mm margin to encompass the microscopic extension of the gross tumor, the whole nasopharynx, the high-risk structures recommended for CTVp2 by the contouring consensus* (such as parapharyngeal space, skull base, pterygopalatine fossa and the inferior part of the nasal cavity and maxillary sinus), the VIIa, and the retrostyloid space above the bilateral transverse process of C1. Low-risk CTV2: N0/positive RPLN only: Bilateral cervical nodal region with the 3-cm caudal expansion below transverse process of C1, and at least covering the level II. N1-2 (positive cervical LNs): Ipilateral cervical nodal region with the 3-cm expansion below the positive LN (GTVnd), and at least covering the level II; contralateral cervical nodal region with the 3-cm caudal expansion below the transverse process of C1, and at least covering the level II. Suspicious LN: 1-cm expansion below the suspicious LN (GTVnd-suspicious)
High-risk CTV1 : GTVnx plus a 10-mm margin to encompass the microscopic extension of the gross tumor, the whole nasopharynx, the high-risk structures recommended for CTVp2 by the contouring consensus* (such as parapharyngeal space, skull base, pterygopalatine fossa and the inferior part of the nasal cavity and maxillary sinus), the VIIa, and the retrostyloid space above the bilateral transverse process of C1. Low-risk CTV2: N0/positive RPLN only: Bilateral level III + Va N1-2 (positive cervical LNs): At least one subsequent level below CTV1
Outcomes
Primary Outcome Measures
Regional-recurrence-free survival
measured from the registration to the documented regional recurrence
Secondary Outcome Measures
Overall survival
measured from registration to documented death from any cause or last follow-up
Distant metastasis-free survival
measured from registration to documented distant metastasis or death from any cause
Progression-free survival
measured from registration to documented locoregional recurrence or distant metastasis or death from any cause
Number of Participants with acute and late radiation-related toxicities
Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 4.0 scale. Acute radiation-related toxicities include dermatitis, mucositis, dry mouth, dysphagia, trismus, and subcutaneous soft tissue. Late radiation toxicities are assessed according to the Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme, including skin, neck tissue damage, hypothyroidism, dry mouth, dysphagia, trismus, and other adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05145660
Brief Title
Optimization of Cervical Nodal CTV for Early and Medium Stage NPC
Official Title
Optimization of Cervical Nodal Clinical Tumor Volume for Early and Medium Stage Nasopharyngeal Carcinoma: a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun-Lin Yi, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.
Detailed Description
ISRT-NPC is a prospective, multicenter, open-label, noninferiority, phase III randomized controlled trial. A total of 488 patients will be randomly assigned in a 1:1 ratio to receive ISI or ERI. Randomization will be stratified by institution and N stage. Generally, in the ISI group, the high-risk CTV1 (dose: 60 Gy) includes a 1-cm expansion of the positive LN as well as the VIIa and the retrostyloid space above the bilateral transverse process of the atlantoaxial spine (C1), regardless of N status. The low-risk CTV2 (Dose: 50 Gy) covers the cervical nodal region with a 3-cm caudal expansion below the transverse process of C1 for N0 disease and a 3-cm expansion below the positive LN for positive LNs (at least covering the level II).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Involved site irradiation
Arm Type
Experimental
Arm Description
High-risk CTV1 : GTVnx plus a 10-mm margin to encompass the microscopic extension of the gross tumor, the whole nasopharynx, the high-risk structures recommended for CTVp2 by the contouring consensus* (such as parapharyngeal space, skull base, pterygopalatine fossa and the inferior part of the nasal cavity and maxillary sinus), the VIIa, and the retrostyloid space above the bilateral transverse process of C1.
Low-risk CTV2:
N0/positive RPLN only: Bilateral cervical nodal region with the 3-cm caudal expansion below transverse process of C1, and at least covering the level II.
N1-2 (positive cervical LNs): Ipilateral cervical nodal region with the 3-cm expansion below the positive LN (GTVnd), and at least covering the level II; contralateral cervical nodal region with the 3-cm caudal expansion below the transverse process of C1, and at least covering the level II.
Suspicious LN: 1-cm expansion below the suspicious LN (GTVnd-suspicious)
Arm Title
Elective region irradiation
Arm Type
Active Comparator
Arm Description
High-risk CTV1 : GTVnx plus a 10-mm margin to encompass the microscopic extension of the gross tumor, the whole nasopharynx, the high-risk structures recommended for CTVp2 by the contouring consensus* (such as parapharyngeal space, skull base, pterygopalatine fossa and the inferior part of the nasal cavity and maxillary sinus), the VIIa, and the retrostyloid space above the bilateral transverse process of C1.
Low-risk CTV2:
N0/positive RPLN only: Bilateral level III + Va N1-2 (positive cervical LNs): At least one subsequent level below CTV1
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiotherapy (IMRT) with reduced-volume
Other Intervention Name(s)
intensity-modulated radiotherapy
Intervention Description
PGTVnx: 69.9Gy/2.12Gy/33f GTVrpn: 69.9Gy/2.12Gy/33f GTVnd: 69.9Gy/2.12Gy/33f GTVnd-suspicious: 60.06Gy/1.82Gy/33f PTV1: 60.06Gy/1.82Gy/33f PTV2: 50.96Gy/1.82Gy/28f
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Concurrent cisplatin (100 mg/m², d1-3, Q3w, maximum to three cycles); The application of induction chemotherapy and consolidation chemotherapy is dependent on the physician's discretion.
Primary Outcome Measure Information:
Title
Regional-recurrence-free survival
Description
measured from the registration to the documented regional recurrence
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
measured from registration to documented death from any cause or last follow-up
Time Frame
3-year
Title
Distant metastasis-free survival
Description
measured from registration to documented distant metastasis or death from any cause
Time Frame
3-year
Title
Progression-free survival
Description
measured from registration to documented locoregional recurrence or distant metastasis or death from any cause
Time Frame
3-year
Title
Number of Participants with acute and late radiation-related toxicities
Description
Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 4.0 scale. Acute radiation-related toxicities include dermatitis, mucositis, dry mouth, dysphagia, trismus, and subcutaneous soft tissue. Late radiation toxicities are assessed according to the Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme, including skin, neck tissue damage, hypothyroidism, dry mouth, dysphagia, trismus, and other adverse events.
Time Frame
8-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Age between 18 and 75 years;
Karnofsky performance status (KPS) score ≥ 70;
Pathologically confirmed World Health Organization (WHO) type II-III NPC;
TNM stage I-III (T1-3N0-2M0) according to the 8th American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) staging system with a maximum diameter (MAD) of cervical involved LNs ≤ 3 cm, namely LB-LN;
Available baseline nasopharynx and neck computed tomography (CT) or magnetic resonance imaging (MRI) (strongly advocated) data (including functional MRI sequences) and measurable tumor lesions;
All procedures for defining the tumor burden completed within 4 weeks of registration;
Survival expectancy of at least 6 months;
Normal marrow and organ function: hemoglobin ≥ 120 g/L, WBCs ≥ 4 × 109 /L, platelets ≥ 100 × 109 /L; liver and kidney function-related indicators within 1.25*the normal upper limit;
Patient willingness to comply with the protocol;
Patient willingness and ability to provide an informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junlin Yi, doctor
Phone
13661217998
Email
yijunlin1969@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junlin Yi
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junlin Yi, MD
Phone
861087788504
Email
yijunlin1969@163.com
12. IPD Sharing Statement
Learn more about this trial
Optimization of Cervical Nodal CTV for Early and Medium Stage NPC
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