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

NCT03283293 | Completed Phase 2 DMC

• 1 other identifier: CTV Delineation after NACT
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Neoadjuvant Chemotherapy; Intensity-modulated Radiation Therapy; Target Volume Delineation; Locoregional Failure Pattern; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 5-year loco-regional recurrence free survival (LRRFS)

  Five years

Secondary Outcomes (7)

• 5-year local recurrence free survival (LRFS)

  Five years

• 5-year regional recurrence free survival (RRFS)

  Five years

• 5-year distant metastasis free survival (DMFS)

  Five years

• 5-year disease specific survival (DSS)

  Five years

• 5-year overall survival (OS)

  Five years

Study Arms (1)

Target volume delineation after NACT

EXPERIMENTAL

Radiation: Target Volume Delineation after NACT

Interventions

Target Volume Delineation after NACT RADIATION

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.

Target volume delineation after NACT

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chong Zhao

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 14, 2017
• Study Start: February 1, 2001
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2008
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

CN (1)