A Phase I/II Study of the Use of Intensity Modulated Radi... | NCT02055989

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

NCT02055989

Sponsor

Royal Marsden NHS Foundation Trust

Status

Completed

Last Update Posted

Feb 5, 2014Estimated

Enrollment

105Actual

Phase

Phase 1Phase 2

Conditions

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

Interventions

Dose-escalated radiotherapy level 1
Sequential dose-escalated radiotherapy level 2

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose-escalated radiotherapy level 1	Experimental		Radiation: Dose-escalated radiotherapy level 1
Sequential dose-escalated radiotherapy level 2	Experimental		Radiation: Sequential dose-escalated radiotherapy level 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dose-escalated radiotherapy level 1	Radiation		Dose-escalated radiotherapy level 1
Sequential dose-escalated radiotherapy level 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Acute toxicity		Up to 3 months after radiotheapy
Late toxicity		Up to 60 months after radiotherapy
Local control

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided