NCT04278638

Brief Summary

The incidence of laryngeal cancer accounts for about 1 \~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

4.5 years

First QC Date

January 16, 2020

Last Update Submit

October 21, 2020

Conditions

Laryngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 2-year local recurrence rate

    In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence. Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence.

    2 year

Secondary Outcomes (5)

  • 2-year disease free survival

    2 years

  • 2-year overall survival

    2 years

  • tissue necrosis

    2 years

  • fibrosis

    2 years

  • time of wound healing

    up to 1 month

Other Outcomes (1)

  • pharyngeal fistula

    3 months

Study Arms (2)

with IORT

EXPERIMENTAL
Radiation: IORTProcedure: surgeryRadiation: External radiotherapy

without IORT

ACTIVE COMPARATOR
Procedure: surgeryRadiation: External radiotherapy

Interventions

IORTRADIATION

IORT in surgery of laryngocarcinoma

with IORT
surgeryPROCEDURE

total laryngectomy or hemilaryngectomy

with IORTwithout IORT
External radiotherapyRADIATION

External radiotherapy

with IORTwithout IORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults over the age of 18;
  • radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
  • the expected survival time ≥ 3 months;
  • sign informed consent for treatment and research with self-knowledge.

You may not qualify if:

  • there is distant metastasis;
  • pregnant women;
  • patients with CT/MRI contraindications;
  • the patient fails to receive treatment and/or follow-up as scheduled;
  • bad fluid and organ function decompensation;
  • multiple primary cancers;
  • patients participating in other trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (1)

  • Yang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1.

    PMID: 32762662DERIVED

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Central Study Contacts

Xinyuan Gong

CONTACT

+8613436640313gxy0007@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of head and neck surgery division

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 20, 2020

Study Start

January 1, 2018

Primary Completion

July 1, 2022

Study Completion

December 1, 2023

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)