Head and Neck CancerNCT01709006
Phase I-II Study on Treatment of Advanced Oropharynx Cancer in Elderly Population by Intensity Modulated Radiotherapy With Treatment Volume Reduction and Combination Chemotherapy
A study testing 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 in people with Head and Neck Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to 18 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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:
- Medical history and physical examination within 28 days of enrolment to the study.
- PET-CT-scan of the neck and MRI of the neck within 6 weeks of enrolment to the study.
- 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)
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- 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.
Who cannot join
- 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:
- Significant cardiac event including i. Unstable angina or symptomatic cardiac insufficiency within 6 months of participation to the study.
- 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.
- 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:
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- 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.
- Uncontrolled, active or serious infection requiring an intravenous treatment at the time of enrolment.
- Uncontrolled pulmonary disease or oxygen need.
- Past history of immunodeficiency including a diagnosis of HIV.
- Any other medical condition that could be exacerbated by the treatment offered in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Head and Neck Cancer
- Being tested
- 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
- Keywords
- Head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 fractionsRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy | Other | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain a locoregional control that is similar to historical data
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.
Measured: April 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completion15 Jul 2017
- Study completion18 Jul 2017
Why it stopped: Not enough patients to conclude
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IMRT by helical tomotherapy with concomitant chemotherapy at 70 Gy in 33 fractions on GTV, 59.4 Gy in 33 fractions on CTV1 and 43.2 Gy in 24 fractions on CTV 2, where CTV 2 would include only level 2 and 3 contralateral and ipsilateral level 4.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuc Félix Nguyen-Tan, md, Principal investigator, CHUM - Hôpital Notre-Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709006
- Sponsor's protocol ID
- ORL IMRT/Elderly population
- Status last verified
- Dec 2017
- First submitted
- 16 Oct 2012
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01709006
- Acronym / sponsor ID
- ORL IMRT/Elderly population
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients to conclude
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Aug 2012
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IMRT by helical tomotherapy with concomitant chemotherapy at 70 Gy in 33 fractions on GTV, 59.4 Gy in 33 fractions on CTV1 and 43.2 Gy in 24 fractions on CTV 2, where CTV 2 would include only level 2 and 3 contralateral and ipsilateral level 4.
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy | Other | 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 fractionsModulated 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 |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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:
- 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.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 fractionsModulated 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 | Radiation therapy |
Primary outcome
Obtain a locoregional control that is similar to historical data
Time frame: April 2015
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.
Results and safety
The study was stopped early (reason given: Not enough patients to conclude). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuc Félix Nguyen-Tan, md principal investigator
CHUM - Hôpital Notre-Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Head and Neck Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patients to conclude). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain a locoregional control that is similar to historical data (time frame: April 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.