NCT00188318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

11.9 years

First QC Date

September 9, 2005

Last Update Submit

February 8, 2016

Conditions

Carcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

  • Toxicities as per CTCAE

    1 yr

Study Arms (1)

Hyperfractionated Accelerated Radiotherapy

EXPERIMENTAL

Hypofractionated Accelerated Radiotherapy with integrated neck surgery

Procedure: hyperfractionated accelerated radiotherapy

Interventions

hyperfractionated accelerated radiotherapyPROCEDURE
Hyperfractionated Accelerated Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • John Waldron, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

June 1, 1998

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

CA(1)