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New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma by AJCC V8 Stage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New-mode reduce-volume target IMRT
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma by AJCC V8 Stage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; No distant metastatic; Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital; Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; Signing informed consent; Follow up regularly and comply with test requirements. Exclusion Criteria: Disease progression during IMRT; Previous malignancy or other concomitant malignant diseases; The evaluation information of tumor efficacy can not be obtained; Receive blind treatment in other clinical research; Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer); Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; Active systemic infection; No or limited capacity for civil conduct; The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; Pregnancy or lactation period;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    New-mode reduced CTVp

    Conventional CTVp

    Arm Description

    Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 8 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)

    Patients with newly diagnosed, non-metastatic NPC was given conventional reduce-volume target IMRT. The CTVp was defined as GTVnx + entire nasopharynx mucosa + 8 mm + corresponding anatomical structures.

    Outcomes

    Primary Outcome Measures

    Local failure-free survival (LFFS)
    The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095154
    Brief Title
    New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma
    Official Title
    New-mode Clinical Target Volume Delineation and Dosimetric Analysis in Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a randomized, phase II, prospective, Single center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of reduced volume IMRT versus conventional IMRT, and compare the radiotherapy-related adverse events and quality of life in two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma by AJCC V8 Stage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    New-mode reduced CTVp
    Arm Type
    Experimental
    Arm Description
    Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 8 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)
    Arm Title
    Conventional CTVp
    Arm Type
    No Intervention
    Arm Description
    Patients with newly diagnosed, non-metastatic NPC was given conventional reduce-volume target IMRT. The CTVp was defined as GTVnx + entire nasopharynx mucosa + 8 mm + corresponding anatomical structures.
    Intervention Type
    Radiation
    Intervention Name(s)
    New-mode reduce-volume target IMRT
    Intervention Description
    The CTVp was defined as a subclinical disease consisting of 8 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)
    Primary Outcome Measure Information:
    Title
    Local failure-free survival (LFFS)
    Description
    The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; No distant metastatic; Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital; Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; Signing informed consent; Follow up regularly and comply with test requirements. Exclusion Criteria: Disease progression during IMRT; Previous malignancy or other concomitant malignant diseases; The evaluation information of tumor efficacy can not be obtained; Receive blind treatment in other clinical research; Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer); Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; Active systemic infection; No or limited capacity for civil conduct; The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; Pregnancy or lactation period;

    12. IPD Sharing Statement

    Learn more about this trial

    New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

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