Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT) | NCT00188318

Studies
Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)

NCT00188318

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Feb 9, 2016Estimated

Enrollment

169Actual

Phase

Phase 2

Conditions

Carcinoma, Squamous Cell

Interventions

hyperfractionated accelerated radiotherapy

Countries

Canada

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

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

Jun 1998

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

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 8, 2016

Last Update Posted Date

Feb 9, 2016Estimated

Name	Class
Princess Margaret Hospital, Canada	OTHER

Description Module

Brief Summary

This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

169Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperfractionated Accelerated Radiotherapy	Experimental	Hypofractionated Accelerated Radiotherapy with integrated neck surgery	Procedure: hyperfractionated accelerated radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyperfractionated accelerated radiotherapy	Procedure		Hyperfractionated Accelerated Radiotherapy

Measure	Description	Time Frame
Toxicities as per CTCAE		1 yr

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven squamous cell carcinoma
Larynx & pharynx (except Nasopharyngeal carcinoma)
Stage III & IV, but any stage hypopharynx
Informed Consent

Exclusion Criteria:

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Waldron, MD	Princess Margaret Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided