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IORT in Local Advanced Laryngocarcinoma (ILAL)

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ClinicalTrials.gov Identifier: NCT04278638
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
LiLi, Tianjin First Central Hospital

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 .

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Radiation: IORT Procedure: surgery Radiation: External radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Experimental: with IORT Radiation: IORT
IORT in surgery of laryngocarcinoma

Procedure: surgery
total laryngectomy or hemilaryngectomy

Radiation: External radiotherapy
External radiotherapy

Active Comparator: without IORT Procedure: surgery
total laryngectomy or hemilaryngectomy

Radiation: External radiotherapy
External radiotherapy




Primary Outcome Measures :
  1. 2-year local recurrence rate [ Time Frame: 2 year ]

    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.



Secondary Outcome Measures :
  1. 2-year disease free survival [ Time Frame: 2 years ]

    Compare 2-year disease free survival in patients with local advanced laryngocarcinoma treated with or without IORT.

    Criteria for disease free survival means MRI and laryngoscopy (PET-CT if possible) indicate tumor free.


  2. 2-year overall survival [ Time Frame: 2 years ]
    Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT.

  3. tissue necrosis [ Time Frame: 2 years ]
    Compare the risk of tissue necrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT.

  4. fibrosis [ Time Frame: 2 years ]
    Compare the risk of fibrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT.

  5. time of wound healing [ Time Frame: up to 1 month ]
    Compare the time of wound healing after surgery in patients with local advanced laryngocarcinoma treated with or without IORT.


Other Outcome Measures:
  1. pharyngeal fistula [ Time Frame: 3 months ]
    Pharyngeal fistula means that saliva is stored in subcutaneous or subincisional tissues, resulting in abscess cavity rupture to the skin or incision margin, making the hypopharyngeal and esophageal lumen communicate with the skin to form a sinus tract, through which saliva or food can spill out to the skin, forming a skin fistula.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278638


Contacts
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Contact: Xinyuan Gong +8613436640313 gxy0007@163.com

Locations
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China, Tianjin
Tianjin First Central Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Xinyuan Gong    +8613436640313    gxy0007@163.com   
Sponsors and Collaborators
Tianjin First Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LiLi, director of head and neck surgery division, Tianjin First Central Hospital
ClinicalTrials.gov Identifier: NCT04278638    
Other Study ID Numbers: 2019008
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases