NCT00497406

Brief Summary

A study for head and neck cancer patients to evaluate the feasibility of combining salivary gland transfer surgical procedure and IMRT helical tomotherapy to reduce dryness of mouth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

10.8 years

First QC Date

July 3, 2007

Last Update Submit

March 14, 2016

Conditions

Head and Neck Cancer

Keywords

submandibular salivary gland transferintensity-modulated radiation therapyhelical tomotherapyreduction of xerostomia

Outcome Measures

Primary Outcomes (1)

  • reduction of Xerostomia after surgery

    combining submandibular salivary gland transfer procedure and intensity modulated radiation therapy (helical tomotherapy) to reduce dryness of mouth in head and neck cancer patients after surgery

    2-3 weeks after surgery, 6 months and 12 months

Interventions

Salivary gland transferPROCEDURE

Retrograde flow method

Helical Tomotherapy treatmentPROCEDURE

total of 30 fractions

Eligibility Criteria

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

You may qualify if:

  • histologically-proven newly-diagnosed squamous cell carcinoma of oropharynx, larynx, hypopharynx and unknown primary of cancer with neck node metastasis after primary surgery
  • AJCC stage I-IV patients are eligible provided they are MO and NO-2b
  • years of age or older
  • KPS of 70 or greater

You may not qualify if:

  • N3/N2C disease or M1 disease
  • salivary gland disease i.e. Sjogren's syndrome
  • prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • prior radiotherapy to the head and neck region
  • lymph node involvement (level I-III) or proximity of disease to submandibular gland on the side chosen for salivary gland transfer on frozen section or permanent pathological evaluation
  • pre-epiglottic space involvement on pathological examination
  • involvement of level I nodes on either side of neck
  • post-op recurrent disease at presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Rufus Scrimger, MD, FRCPC

    AHS Cancer Control Alberta

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 6, 2007

Study Start

December 1, 2005

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

CA(1)