Brief Title
Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT
Official Title
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)
Brief Summary
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
5-year loco-regional recurrence free survival (LRRFS)
Secondary Outcome
5-year local recurrence free survival (LRFS)
Condition
Nasopharyngeal Carcinoma
Intervention
Target Volume Delineation after NACT
Study Arms / Comparison Groups
Target volume delineation after NACT
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
112
Start Date
February 2001
Completion Date
April 2008
Primary Completion Date
April 2007
Eligibility Criteria
Inclusion Criteria:
1. histologically confirmed NPC;
2. no evidence of distant metastasis;
3. no previous treatment for NPC;
4. stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
5. adequate liver, renal and bone marrow function;
6. Karnofsky Performance Status (KPS) ≥80 scores.
Exclusion Criteria:
1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or
neck dissection prior NACT;
2. disease progression during NACT;
3. presence of distant metastasis;
4. pregnancy or lactation;
5. previous malignancy or other concomitant malignant disease.
Gender
All
Ages
14 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Chong Zhao, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03283293
Organization ID
CTV Delineation after NACT
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Chong Zhao, Principal Investigator, Sun Yat-sen University
Verification Date
February 2019