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

Phase 1/Phase 2
70 Years
80 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

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

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

1. Medical history and physical examination within 28 days of enrolment to the

2. PET-CT-scan of the neck and MRI of the neck within 6 weeks of enrolment to the

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Obtain a locoregional control that is similar to historical data

Outcome Description:

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.

Outcome Time Frame:

April 2015

Safety Issue:


Principal Investigator

Phuc Félix Nguyen-Tan, md

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHUM - Hôpital Notre-Dame


Canada: Ethics Review Committee

Study ID:

ORL IMRT/Elderly population



Start Date:

October 2012

Completion Date:

April 2015

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms