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A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx

Primary Purpose

Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers, Locally Advanced Thyroid Cancers

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Dose-escalated radiotherapy level 1
Sequential dose-escalated radiotherapy level 2
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
  2. Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
  3. Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation.
  4. High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique).
  5. Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted.
  6. Stage T1-4, N1-3, M0 disease
  7. Zubrod Performance Status 0-2

Exclusion Criteria:

  1. Previous radiotherapy to the head and neck region
  2. Previous malignancy except non-melanoma skin cancer
  3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
  4. Prophylactic use of amifostine or pilocarpine is not allowed
  5. Brachytherapy is not allowed as part of the treatment

Sites / Locations

  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose-escalated radiotherapy level 1

Sequential dose-escalated radiotherapy level 2

Arm Description

Outcomes

Primary Outcome Measures

The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.

Secondary Outcome Measures

Acute toxicity
Late toxicity
Local control
Loco-regional control
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Disease free survival
Overall Survival

Full Information

First Posted
February 4, 2014
Last Updated
February 4, 2014
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02055989
Brief Title
A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
Official Title
A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased. This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. These two groups of patients are being treated differently and will be analysed separately. The primary objective of this Phase I sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens. DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily fractions and elective nodal levels 54 Gy in 30 daily fractions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers, Locally Advanced Thyroid Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose-escalated radiotherapy level 1
Arm Type
Experimental
Arm Title
Sequential dose-escalated radiotherapy level 2
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Dose-escalated radiotherapy level 1
Intervention Type
Radiation
Intervention Name(s)
Sequential dose-escalated radiotherapy level 2
Primary Outcome Measure Information:
Title
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
Time Frame
12 months after radiotherapy
Secondary Outcome Measure Information:
Title
Acute toxicity
Time Frame
Up to 3 months after radiotheapy
Title
Late toxicity
Time Frame
Up to 60 months after radiotherapy
Title
Local control
Time Frame
Up to 60 months after radiotherapy
Title
Loco-regional control
Time Frame
Up to 60 months after radiotherapy
Title
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Time Frame
Up to 60 months after radiotherapy
Title
Disease free survival
Time Frame
Up to 60 months after radiotherapy
Title
Overall Survival
Time Frame
Up to 60 months after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck. Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid. Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation. High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique). Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted. Stage T1-4, N1-3, M0 disease Zubrod Performance Status 0-2 Exclusion Criteria: Previous radiotherapy to the head and neck region Previous malignancy except non-melanoma skin cancer Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up Prophylactic use of amifostine or pilocarpine is not allowed Brachytherapy is not allowed as part of the treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris M Nutting, PhD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx

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