Back to resultsDose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Primary Purpose
Injury; Temporal Region
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Injury; Temporal Region focused on measuring Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- Age between 18 years and 70 years.
- Karnofsky score ≥80
- WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.
- Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable.
- Signed study-specific consent form prior to study entry.
Exclusion Criteria:
- Stage IVB
- Evidence of distant metastases
- Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
- Previous chemotherapy ≤ 6 months prior to study entry
- Patient is on other experimental therapeutic cancer treatment
- Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years
- Active untreated infection
- Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy
- Pregnant women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMRT with and without chemotherapy
Arm Description
Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
Outcomes
Primary Outcome Measures
The incidence of radiation-induced temporal lobe injury at 5 years
The incidence of radiation-induced temporal lobe injury at 5 years will be calculated
Secondary Outcome Measures
Local recurrence-free survival at 5 years
Local recurrence-free survival at 5 years will be calculated
Full Information
NCT ID
NCT03539250
First Posted
March 10, 2018
Last Updated
May 25, 2018
Sponsor
Jiangxi Provincial Cancer Hospital
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03539250
Brief Title
Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Official Title
Dose Constraints for the Temporal Lobes During the Optimization of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 10, 2018 (Anticipated)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi Provincial Cancer Hospital
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
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
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.
Detailed Description
The prescribe dose was 66-70Gy to the PTV of the GTVnx, 60Gy to the PTV of CTV1(i.e., high-risk regions),54-56Gy to the PTV of CTV2(i.e., low-risk regions),and 64-66Gy to the PTV of the GTVnd for the metastatic cervical lymph nodes in 30-33 fractions. For the GTV and CTV, the target volumes that received more than 95% of the prescribed dose was used to reflect the target coverage. Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury; Temporal Region
Keywords
Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated 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
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMRT with and without chemotherapy
Arm Type
Experimental
Arm Description
Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
IMRT with and without chemotherapy
Primary Outcome Measure Information:
Title
The incidence of radiation-induced temporal lobe injury at 5 years
Description
The incidence of radiation-induced temporal lobe injury at 5 years will be calculated
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Local recurrence-free survival at 5 years
Description
Local recurrence-free survival at 5 years will be calculated
Time Frame
5 years
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-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.
No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
Age between 18 years and 70 years.
Karnofsky score ≥80
WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.
Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable.
Signed study-specific consent form prior to study entry.
Exclusion Criteria:
Stage IVB
Evidence of distant metastases
Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
Previous chemotherapy ≤ 6 months prior to study entry
Patient is on other experimental therapeutic cancer treatment
Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years
Active untreated infection
Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zeng, MD
Phone
(86)0791-88314495
Email
zlsports100@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Gao Li, MD
Organizational Affiliation
Jiangxi cancer hospital, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
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