Head and Neck CancerPhase 3SHORT-OPCNCT04178174
Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
A Phase 3 study testing SABR boost and de-escalated chemoradiation and Standard chemoradiation in people with Head and Neck Cancer and Oropharynx Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial summary
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharynx Cancer, Human Papilloma Virus
- What is being tested?
- SABR boost and de-escalated chemoradiation and Standard chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Feb 2020to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
- Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
- Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
Show all 9Show fewer
- Primary tumor < 30 cc
- Planned for curative chemoradiation
- For females of child-bearing age, a negative pregnancy test
Who cannot join
- Clinical N3 classification, as per AJCC 8th edition
- Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
- Previous irradiation of the head and neck region
- Previous surgery of the HNC region (except for incisional or excisional biopsies)
- Pregnancy or breastfeeding
- Connective tissue disease
Show all 9Show fewer
- Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
- Non-Cisplatin concurrent chemotherapy
- Prior induction chemotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Center
London, Ontario
Karen Eddy, (519) 685-8500, Karen.Eddy@lhsc.on.ca
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 1R6
Mom Phat, 514-890-8000 ext. 26906, mom.phat.chum@ssss.gouv.qc.ca
Houda Bahig
About this study
Official title: Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
Read the detailed description
Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of ~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.
Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.
The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).
This is an open label randomized phase III non inferiority trial. Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage and use of concurrent chemotherapy.
- Being tested
- SABR boost and de-escalated chemoradiation, Standard chemoradiation
- Keywords
- head and neck cander, Oropharynx cancer, Human papilloma virus, Radiotherapy, Stereotactic body radiotherapy, Chemotherapy, De-intensification
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABR boost and de-escalated chemoradiationRadiation
Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
Standard chemoradiationRadiation
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
| Study group | Role | What they receive |
|---|---|---|
| SABR boost and de-escalated chemoradiation | Experimental | SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2. Receives: Radiation: SABR boost and de-escalated chemoradiation |
| Standard chemoradiation | Active comparator | The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2. Receives: Radiation: Standard chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation
Measured: 2 years after the end of chemoradiation
Secondary outcomes (8)
Subacute toxicity
Rate of grade ≥ 3 subacute toxicity
Measured: Between 2 and 6 months after the end of chemoradiation
Acute toxicity
Rate of grade ≥ 3 acute toxicity
Measured: Less than 2 months after the end of chemoradiation
Late toxicity
Rate of grade ≥ 3 late toxicity
Measured: Between 6 months and 5-years after the end of chemoradiation
OS
Overall survival
Measured: At 2- and 5-years after the end of chemoradiation
locoregional control
Patient alive with locoregional control
Measured: At 2- and 5-years after the end of chemoradiation
Head and neck symptom burden
Patient-reported head and neck symptom burden as measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module. The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
Measured: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Dysphagia
Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
Measured: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Time from treatment start to return to work
Time from first day of treatment start to first day of return to work.
Measured: Measured in days and reported at 2-years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start23 Feb 2020
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Jewish General Hospital
- Responsible party
- Sponsor
- Investigators
- Houda Bahig, MD PhD, Study chair, Centre hospitalier de l'Université de Montréal (CHUM)Phuc-Felix Nguyen-Tan, MD, Study chair, Centre hospitalier de l'Université de Montréal (CHUM)David Palma, MD PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sJack Phan, MD PhD, Principal investigator, M.D. Anderson Cancer CenterKhalil Sultanem, MD, Principal investigator, Montreal Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178174
- Sponsor's protocol ID
- SHORT-OPC
- Acronym
- SHORT-OPC
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2019
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
PubMed 42032732
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial
- ClinicalTrials.gov ID
- NCT04178174
- Acronym / sponsor ID
- SHORT-OPC / SHORT-OPC
- Keywords
- head and neck cander, Oropharynx cancer, Human papilloma virus, Radiotherapy, Stereotactic body radiotherapy, Chemotherapy, De-intensification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Jewish General Hospital
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Nov 2019 (actual)
- 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.
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
Detailed description
Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of ~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.
Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.
The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).
This is an open label randomized phase III non inferiority trial. Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage and use of concurrent chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SABR boost and de-escalated chemoradiation | Experimental | Radiation: SABR boost and de-escalated chemoradiationSABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2. |
| Standard chemoradiation | Active comparator | Radiation: Standard chemoradiationThe standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
- Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
Key exclusion criteria (9 listed)
- Clinical N3 classification, as per AJCC 8th edition
- Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
- Previous irradiation of the head and neck region
- Previous surgery of the HNC region (except for incisional or excisional biopsies)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| SABR boost and de-escalated chemoradiationStereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions | Radiation | SABR boost and de-escalated chemoradiation |
| Standard chemoradiationStandard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions | Radiation | Standard chemoradiation |
Primary outcome
Progression free survival
Time frame: 2 years after the end of chemoradiation
Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation
8 secondary outcomes
Subacute toxicity
Time frame: Between 2 and 6 months after the end of chemoradiation
Acute toxicity
Time frame: Less than 2 months after the end of chemoradiation
Late toxicity
Time frame: Between 6 months and 5-years after the end of chemoradiation
OS
Time frame: At 2- and 5-years after the end of chemoradiation
locoregional control
Time frame: At 2- and 5-years after the end of chemoradiation
Head and neck symptom burden
Time frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Dysphagia
Time frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Time from treatment start to return to work
Time frame: Measured in days and reported at 2-years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 42032732Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
- Individual participant dataSharing planned: No
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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.
Houda Bahig, MD PhD study chair
Centre hospitalier de l'Université de Montréal (CHUM)
Phuc-Felix Nguyen-Tan, MD study chair
Centre hospitalier de l'Université de Montréal (CHUM)
David Palma, MD PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SABR boost and de-escalated chemoradiation and Standard chemoradiation in people with Head and Neck Cancer and Oropharynx Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Trudel (514-890-8254, diane.dt.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years after the end of chemoradiation). 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 NCT04178174, 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 24 Aug 2026.