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

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Target Volume Delineation after NACT

• Registration Number: NCT03283293
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2007-04
• Study Completion: 2008-04
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Target volume delineation after NACT	Target Volume Delineation after NACT	-

Primary Outcome Measures

Name	Time	Method
5-year loco-regional recurrence free survival (LRRFS)	Five years

Secondary Outcome Measures

Name	Time	Method
5-year overall survival (OS)	Five years
5-year distant metastasis free survival (DMFS)	Five years
5-year regional recurrence free survival (RRFS)	Five years
Locoregional failure patterns	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.
5-year local recurrence free survival (LRFS)	Five years
5-year disease specific survival (DSS)	Five years
Late toxicities	Five years	The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China