Phase I-II Study on Treatment of Advanced Oropharynx Cancer in Elderly Population by Intensity Modulated Radiotherapy With Treatment Volume Reduction and Combination Chemotherapy

NCT01709006 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-31

No results posted yet for this study

Summary

It is currently estimated that above 50% of new cancer cases are diagnosed in the elderly population\[1\]. With the increased life expectancy in the industrialised countries, the incidence of head and neck cancers has significantly increased in the last decade with rates estimated between 24-40% in patients over 70 years old \[2-4\]. It is estimated that with the improvement in quality of life and treatment modulation, the incidence will continue to rise in the coming years. Because the current available prospective studies often exclude patients above 65 or 70 years old, the data and guidelines on head and neck treatment for these patients population remain limited.

Treatment of elderly patients with advanced stage III-IV oropharyngeal squamous carcinoma with intensity modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions to the first disease-free lymphatic relay bilaterally as well as a combination Cisplatin chemotherapy at a reduced dose.

Conditions

Interventions

RADIATION

Modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions

Modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Phuc Félix Nguyen-Tan, md · CHUM - Hôpital Notre-Dame

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-07-15
Completion
2017-07-18

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709006 on ClinicalTrials.gov