Head and Neck NeoplasmsPhase 2NCT02460471
Palliative Radiotherapy Protocol in Head and Neck Cancer
A Phase 2 study testing palliative radiation therapy in people with Head and Neck Neoplasms and Quality of Life, run by Maisonneuve-Rosemont Hospital at 2 sites in Canada.
Trial summary
Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Quality of Life
- What is being tested?
- palliative radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2011to Apr 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give an informed consent
- Able to complete QOL questionnaires
- Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
- Presence of measurable disease
- Biopsy proven squamous or salivary cancer of the head and neck region
- Expected survival of at least 2 months.
Who cannot join
- Pregnancy
- No previous RT to the neck and no plan to receive concomitant chemotherapy
- Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
- Unavailable for follow-up
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L4M1
About this study
Official title: Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.
Read the detailed description
Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.
- Conditions
- Head and Neck Neoplasms, Quality of Life
- Being tested
- palliative radiation therapy
- Keywords
- Radiotherapy, Palliative Care, IMRT
- 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.
palliative radiation therapyRadiation
thermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin
| Study group | Role | What they receive |
|---|---|---|
| palliative radiation therapy | Experimental | 25 Gy in 5 daily fractions Receives: Radiation: palliative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H\&N35 modules)
Measured: from radiation treatment until 24 months planned follow-up or death
Secondary outcomes (1)
Toxicity (CTCAE v 4.0 graded)
CTCAE v 4.0 graded toxicities
Measured: from radiation treatment until 24 months planned follow-up or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Fortin MD MSc FRCPC, Maisonneuve-Rosemont Hospital
- Investigators
- Bernard Fortin, MD MSc, Principal investigator, Maisonneuve Rosemont Hospital, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460471
- Sponsor's protocol ID
- 11020
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortin B, Khaouam N, Filion E, Nguyen-Tan PF, Bujold A, Lambert L. Palliative Radiation Therapy for Advanced Head and Neck Carcinomas: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):647-53. doi: 10.1016/j.ijrobp.2016.01.039. Epub 2016 Jan 28.
PubMed 27020111
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
- ClinicalTrials.gov ID
- NCT02460471
- Acronym / sponsor ID
- 11020
- Conditions
- Head and Neck Neoplasms, Quality of Life
- Keywords
- Radiotherapy, Palliative Care, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Jun 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Jun 2015 (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.
Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.
Detailed description
Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palliative radiation therapy | Experimental | Radiation: palliative radiation therapy25 Gy in 5 daily fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to give an informed consent
- Able to complete QOL questionnaires
- Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
- Presence of measurable disease
- Biopsy proven squamous or salivary cancer of the head and neck region
Key exclusion criteria (4 listed)
- Pregnancy
- No previous RT to the neck and no plan to receive concomitant chemotherapy
- Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
- Unavailable for follow-up
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 |
|---|---|---|
| palliative radiation therapythermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin | Radiation | palliative radiation therapy |
Primary outcome
Quality of life
Time frame: from radiation treatment until 24 months planned follow-up or death
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H\&N35 modules)
1 secondary outcome
Toxicity (CTCAE v 4.0 graded)
Time frame: from radiation treatment until 24 months planned follow-up or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 27020111Fortin B, Khaouam N, Filion E, Nguyen-Tan PF, Bujold A, Lambert L. Palliative Radiation Therapy for Advanced Head and Neck Carcinomas: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):647-53. doi: 10.1016/j.ijrobp.2016.01.039. Epub 2016 Jan 28.
Related trials for Head and Neck Neoplasms
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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.
Bernard Fortin, MD MSc principal investigator
Maisonneuve Rosemont Hospital, University of Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing palliative radiation therapy in people with Head and Neck Neoplasms and Quality of Life, run by Maisonneuve-Rosemont Hospital at 2 sites 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life (time frame: from radiation treatment until 24 months planned follow-up or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460471, which also lists 1 linked publication.
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 2 Jun 2015.