Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT

Nasopharyngeal Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283293
• Other study ID #: CTV Delineation after NACT
• Status: Completed
• Phase: Phase 2
• Start date: February 2001
• Est. completion date: April 2008

Study information

• Verified date: February 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year loco-regional recurrence free survival (LRRFS)		Five years
Secondary	5-year local recurrence free survival (LRFS)		Five years
Secondary	5-year regional recurrence free survival (RRFS)		Five years
Secondary	5-year distant metastasis free survival (DMFS)		Five years
Secondary	5-year disease specific survival (DSS)		Five years
Secondary	5-year overall survival (OS)		Five years
Secondary	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.	Five years
Secondary	Late toxicities	The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.	Five years