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Status unknownNCT01210872Updated Aug 7, 2013

Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy

An observational study in Head and Neck Cancer, sponsored by Centre Georges Francois Leclerc. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by Centre Georges Francois Leclerc · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study summary

RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.

PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the impact of quality-of-life assessment in routine oncology practice on satisfaction with care, health-related quality-of-life, and toxicity in patients with primary nonmetastatic head and neck cancer treated with radiotherapy.

Secondary

  • To evaluate the feasibility of using quality-of-life tools in routine oncology practice.
  • To evaluate the impact on the occurrence of toxicity.
  • To determine the impact on overall survival.
  • To study the concordance between the toxicity reported by the clinician and those reported by the patient quality-of-life questionnaires.

OUTLINE: Patients are stratified according to sex, tumor localization, and TNM stage. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients complete quality-of-life questionnaires (EORTC tools only, including EORTC QLQ-SAT32, EORTC QLQ-C30, and specific module QLQ-H\&N35/Euroqol EQ-5D) before each consultation with the clinician for one year.
  • Arm II: Patients undergo standard follow-up care comprising consultation with the clinician for one year.

After completion of study, patients are followed up every 3 months for 1 year and then at 2 years.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage I lymphoepithelioma of the oropharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage I lymphoepithelioma of the nasopharynx
  • stage II lymphoepithelioma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage I squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage I squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage I verrucous carcinoma of the larynx
  • stage II verrucous carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • tongue cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary nonmetastatic head and neck cancer
  • No other primary cancer localizations
  • No second tumor localization at the time of diagnosis
  • Must be planning to be treated initially with radiotherapy

PATIENT CHARACTERISTICS:

  • No cognitive impairment or psychiatric history
  • No history of other cancer

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
05

Study design

Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Otherquestionnaire administration
  • Procedurequality-of-life assessment
  • Procedurestandard follow-up care
06

What researchers measure

Primary outcomes

  1. Satisfaction of care (EORTC QLQ-SAT32)

  2. Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)

Secondary outcomes

  1. Toxicity (occurrence and length) according to NCI-CTC version 3.0

  2. Overall survival

07

Study locations

1 of 1 sites recruiting
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
    Dijon, 21079, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01210872
Lead sponsor
Centre Georges Francois Leclerc
First posted
Sep 29, 2010
Start date
Sep 2009
Primary completion
Sep 2013 (estimated)
Last update
Aug 7, 2013

Study contacts

Philippe Maingon, MD
study chair · Centre Georges Francois Leclerc
Franck Bonnetain, PhD
Centre Georges Francois Leclerc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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