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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01709006
First received: October 16, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study on Treatment of Advanced Oropharynx Cancer in Elderly Population by Intensity Modulated Radiotherapy With Treatment Volume Reduction and Combination Chemotherapy

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Obtain a locoregional control that is similar to historical data [ Time Frame: April 2015 ] [ Designated as safety issue: Yes ]
    Obtain a locoregional control that is similar to historical data, therefore above 90%, while decreasing toxicity rates related to treatment in an elderly population at risk. We aim to recruit 10 patients for a confidence interval of 72 to 96% on the locoregional control rate. Kaplan-Meier curves will be obtained to calculate the locoregional control rate for these patients. Analysis will be conducted after each group of 5 patients. If a recurrence is document in 1 patient or more outside the CTV in each 5 patients group, the study will be interrupted.


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radiation therapy
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
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

  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Histopathological diagnosis of infiltrating squamous cell cancer of the oropharynx proven by biopsy.

    2. Age ≥70 years but less than 80 years 3. Score ≤ 14 at the G8 questionnaire and a score deficit in ≥2 aspects of the SCGA without contra-indication CTRT (formal evaluation by a geriatrician) 4. ECOG 0-2 5. Stages III to IVa-b (T1-4, N0-2c et N3M0) according to the AJCC without distant metastasis, based on the following investigations:

    1. Medical history and physical examination within 28 days of enrolment to the study.
    2. PET-CT-scan of the neck and MRI of the neck within 6 weeks of enrolment to the study.
    3. CT-Chest or PET scan 6. Performance status: ECOG 0-2 7. Adequate renal, liver and haematological functions within 21 days of enrolment in the study.

      Hematology Absolute neutrophils ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Hemoglobin ≥ 90 g/L (transfusions are permitted)

      Biochemistry Serum creatinine Creatinine clearance ≥ 50 mL/min, calculated according to the Cockcroft-Gault formulae Bilirubin ≤ 1.0 x LSN AST and ALT ≤ 2.5 x LSN

      8. Sexually active men will need to use an adequate contraception method during the treatment and 6 weeks after the treatment end.

      9. An informed consent for participation in the study will need to be obtained. 10. Patients will need to be available for the treatment and follow-up. All participating patients will be treated in our center.

      Exclusion Criteria:

  • 1. Patients with a previous diagnosis of invasive cancer (except basocellular carcinoma of the skin, in-situ carcinoma of the breast, oral cavity or cervix) unless free of disease for at least 3 years.

    2. Presence of a synchronous cancer 3. Previous radiotherapy to the head and neck area 4. Known allergy to Cisplatin 5. Diagnosis of peripheral neuropathy ≥ grade 2 6. Active and/or severe cardiac co-morbidities:

    a. Significant cardiac event including i. Unstable angina or symptomatic cardiac insufficiency within 6 months of participation to the study.

ii. Myocardial infarct within 6 months of enrolment iii. Any cardiac past medical history that increases significantly the risk of cardiac complication according to the investigator.

b. Any past medical history of ventricular arrhythmia c. Uncontrolled hypertension (Systolic arterial pressure of ≥ 160 mmHg or diastolic pressure ≥ 95 mmHg) d. Long QT congenital syndrome e. Left ventricular ejection fraction of less than 45% measured by isotropic ventriculography for patients with a significant cardiac past medical history (myocardial infarct, severe hypertension, arrhythmia or exposition to anthracyclines).

7. Presence of any serious medical condition not allowing the patient to undergo the treatment protocol including, but not limited to:

  1. Past medical history of significant neurological or psychiatric disorder (ex: uncontrolled psychotic disorder) preventing an informed consent or that would limit compliance to treatment and follow-up.
  2. Uncontrolled, active or serious infection requiring an intravenous treatment at the time of enrolment.
  3. Uncontrolled pulmonary disease or oxygen need.
  4. Past history of immunodeficiency including a diagnosis of HIV.
  5. Any other medical condition that could be exacerbated by the treatment offered in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709006

Contacts
Contact: Félix Nguyen, md 514-890-8254 felix.nguyen.chum@ssss.gouv.qc.ca

Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Phuc Félix Nguyen-Tan, md CHUM - Hôpital Notre-Dame
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01709006     History of Changes
Other Study ID Numbers: ORL IMRT/Elderly population
Study First Received: October 16, 2012
Last Updated: October 29, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014