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

February 4, 2014 updated by: Royal Marsden NHS Foundation Trust

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose-escalated radiotherapy level 1
Radiation: Dose-escalated radiotherapy level 1
Experimental: Sequential dose-escalated radiotherapy level 2
Radiation: Sequential dose-escalated radiotherapy level 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute toxicity
Time Frame: Up to 3 months after radiotheapy
Up to 3 months after radiotheapy
Late toxicity
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy
Local control
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy
Loco-regional control
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy
Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy
Disease free survival
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy
Overall Survival
Time Frame: Up to 60 months after radiotherapy
Up to 60 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Chris M Nutting, PhD, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 1978

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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