NCT01548846

Brief Summary

This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

March 6, 2012

Last Update Submit

March 12, 2015

Conditions

Head and Neck CancerRadiotherapy by Tomotherapy ExclusiveWith or Without Concurrent Chemotherapy

Keywords

tomotherapyxerostomyhead and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients with xerostomia

    Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.

    12 months after completion of radiotherapy.

Secondary Outcomes (6)

  • Evaluation of acute and late xerostomia

    after 3, 6 and 12 months after radiotherapy

  • Measurement of salivary flow with and without stimulation

    at 3, 6 and 12 months after end of radiotherapy

  • Evaluation of the incidence of acute side effects of radiotherapy

    Weekly during radiotherapy

  • Evaluation of the incidence of late side effects of radiotherapy

    At 3, 6 and 12 months after radiotherapy

  • Evaluation of quality of life and fatigue

    At 3, 6 and 12 months after radiotherapy

  • +1 more secondary outcomes

Interventions

TomotherapyRADIATION

Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT

Eligibility Criteria

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

You may qualify if:

  • Patient (e) old (e) over 18 years
  • Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
  • Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
  • Indication of head and neck radiotherapy bilateral
  • All of the TNM stage except metastatic
  • Patient has signed informed consent for participation in the study
  • Mastery of the French language

You may not qualify if:

  • History of head and neck radiotherapy
  • Indication of head and neck radiotherapy unilateral
  • Personal history of malignant tumors uncontrolled over the past 5 years
  • History of oral sicca syndrome
  • Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
  • Concomitant treatment with amifostine
  • Concomitant treatment with cetuximab
  • Primary tumor of the salivary glands
  • Head and neck hyperfractionated radiotherapy and / or accelerated
  • Head and neck radiotherapy hypofractionated
  • Metastatic disease
  • Patient deprived of liberty, under guardianship
  • Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
  • Refusal of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François BACLESSE

Caen, 14076, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • bernard GERY, MD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 13, 2015

Record last verified: 2014-03

Locations

FR(1)