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

NCT01210872 | Unknown

• 4 other identifiers: CGFL-QDVCDR0000683850CGFL-AFSSAPS-2008-A01468-47EU-21061
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Satisfaction of care (EORTC QLQ-SAT32)

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

Secondary Outcomes (2)

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

• Overall survival

Interventions

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

standard follow-up care PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Philippe Maingon, MD

  Centre Georges Francois Leclerc

  STUDY CHAIR

• Franck Bonnetain, PhD

  Centre Georges Francois Leclerc

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2010-09

Locations

FR (1)