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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Target Volume Delineation after NACT
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Neoadjuvant Chemotherapy, Intensity-modulated Radiation Therapy, Target Volume Delineation, Locoregional Failure Pattern, Nasopharyngeal Carcinoma

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Target volume delineation after NACT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2017
Last Updated
February 11, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03283293
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2001 (Actual)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Neoadjuvant Chemotherapy, Intensity-modulated Radiation Therapy, Target Volume Delineation, Locoregional Failure Pattern, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Target volume delineation after NACT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Target Volume Delineation after NACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
5-year loco-regional recurrence free survival (LRRFS)
Time Frame
Five years
Secondary Outcome Measure Information:
Title
5-year local recurrence free survival (LRFS)
Time Frame
Five years
Title
5-year regional recurrence free survival (RRFS)
Time Frame
Five years
Title
5-year distant metastasis free survival (DMFS)
Time Frame
Five years
Title
5-year disease specific survival (DSS)
Time Frame
Five years
Title
5-year overall survival (OS)
Time Frame
Five years
Title
Locoregional failure patterns
Description
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
Title
Late toxicities
Description
The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Zhao
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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

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