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New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06095154
Collaborator
(none)
100
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: New-mode reduce-volume target IMRT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
New-mode Clinical Target Volume Delineation and Dosimetric Analysis in Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: New-mode reduced CTVp

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)

Radiation: 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)
No Intervention: Conventional CTVp

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.

Outcome Measures

Primary Outcome Measures

  1. Local failure-free survival (LFFS) [36 months]

    The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;

  2. No distant metastatic;

  3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;

  4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;

  5. Signing informed consent;

  6. Follow up regularly and comply with test requirements.

Exclusion Criteria:

  1. Disease progression during IMRT;

  2. Previous malignancy or other concomitant malignant diseases;

  3. The evaluation information of tumor efficacy can not be obtained;

  4. Receive blind treatment in other clinical research;

  5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);

  6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;

  7. Active systemic infection;

  8. No or limited capacity for civil conduct;

  9. 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;

  10. Pregnancy or lactation period;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT06095154
Other Study ID Numbers:
  • NPC009
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Carcinoma

Study Results

No Results Posted as of Oct 23, 2023