A Phase 2 interventional study of Target Volume Delineation after NACT in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Radiation: Target Volume Delineation after NACT
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.
5-year loco-regional recurrence free survival (LRRFS)
Time frame: Five years
5-year local recurrence free survival (LRFS)
Time frame: Five years
5-year regional recurrence free survival (RRFS)
Time frame: Five years
5-year distant metastasis free survival (DMFS)
Time frame: Five years
5-year disease specific survival (DSS)
Time frame: Five years
5-year overall survival (OS)
Time frame: Five years
Locoregional failure patterns
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.
Time frame: Five years
Late toxicities
The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
Time frame: Five years
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University