- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283293
Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT
February 11, 2019 updated by: Zhao Chong, Sun Yat-sen University
Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)
The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose.
Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality.
Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Cancer Center, Sun Yat-sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed NPC;
- no evidence of distant metastasis;
- no previous treatment for NPC;
- stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
- adequate liver, renal and bone marrow function;
- Karnofsky Performance Status (KPS) ≥80 scores.
Exclusion Criteria:
- fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT;
- disease progression during NACT;
- presence of distant metastasis;
- pregnancy or lactation;
- previous malignancy or other concomitant malignant disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target volume delineation after NACT
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The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT.
The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT.
The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area.
The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
5-year loco-regional recurrence free survival (LRRFS)
Time Frame: Five years
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year local recurrence free survival (LRFS)
Time Frame: Five years
|
Five years
|
|
5-year regional recurrence free survival (RRFS)
Time Frame: Five years
|
Five years
|
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5-year distant metastasis free survival (DMFS)
Time Frame: Five years
|
Five years
|
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5-year disease specific survival (DSS)
Time Frame: Five years
|
Five years
|
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5-year overall survival (OS)
Time Frame: Five years
|
Five years
|
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Locoregional failure patterns
Time Frame: Five years
|
The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: "in field" if 95% of Vrecur was within the 95% isodose; "marginal" if 20% to 95% of Vrecur was within the 95% isodose, or "outside" if less than 20% of Vrecur was inside the 95% isodose.
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Five years
|
Late toxicities
Time Frame: Five years
|
The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
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Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chong Zhao, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2001
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
September 11, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (Actual)
September 14, 2017
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 11, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- CTV Delineation after NACT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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