To Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC

• Sponsor: Fujian Cancer Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04387266
• Collaborator: (none)
• Enrollment: 471
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 117.5

Study Details

Study Description

Brief Summary

This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Radiation: modified reduce-volume target IMRT

Study Design

• Study Type: Observational
• Actual Enrollment: 471 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Real-world Study in Patients With Nasopharyngeal Carcinoma: to Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Modified reduce-volume target IMRT Patients with newly diagnosed, non-metastatic NPC was given modified reduce-volume target IMRT

Radiation: modified reduce-volume target IMRT; The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.

Outcome Measures

Primary Outcome Measures

1. Local failure-free survival (LFFS) [60 month]

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

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. Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;

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

4. Diagnosis time: November 1, 2014 to December 31 , 2017

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of radiation oncology, Fujian cancer hospital	Fuzhou	Fujian	China	350014

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: NCT04387266
• Other Study ID Numbers: NPC004
• First Posted: May 13, 2020
• Last Update Posted: Oct 9, 2020
• Last Verified: Oct 1, 2020

• 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 9, 2020