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Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Study acronym: SHORT-OPC
StatusRecruiting
PhasePhase 3
Started2020-02-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2027 → Dec 2028
See other at-risk trials from Centre hospitalier de l'Université de Montréal (CHUM)

Amendment history

2026-08-21
Study Status, Sponsor/Collaborators, Oversight v8
Primary completion pushed: 2027-12 → 2028-12
Completion pushed: 2029-12 → 2030-12
2025-05-14
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility v7
PhasePhase 2→Phase 3
Primary completion date2025-12→2027-12
Completion date2027-12→2029-12
Enrollment target106→360
Eligibility criteria+353 characters
[...] -bearing age, a negative pregnancy test Exclusion Criteria: 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, symp [...] Previous irradiation of the head and neck (HNC) region Previous surgery of the HNC region (except for incisi [...]
Secondary endpoints8 entries, revised
PFSlocoregional control
Primary endpoints1 entry, revised
LocoregionalProgression controlfree survival
Study description-388 characters
[...] Cisplatin 100mg/m2). This is an open label randomized phase IIIII non inferiority trial with 2 planned interim safety (toxicity) analysis and 1 futility (locoregional control) analysis with go/no go decision to pursue the study based on probabilities of toxicities and LRC (Bayesian adaptive design). Patients will be randomized using a 1:1 ratio between the [...] d the experimental arm and will be stratified by tumor stage. At theand significance leveluse of 0concurrent chemotherapy.2 and assuming the LRC rate of 90% for both experimental and control arms, 80% for the non-inferiority test with the ma [...]
2025-03-18
Study Status, Oversight, Contacts/Locations v6
Primary completion date2024-12→2025-12
Completion date2026-12→2027-12
Study sites1→2
2023-12-10
Study Status v5
Primary completion date2023-12→2024-12
Completion date2025-12→2026-12
2022-11-11
2 amendments v3-v4
2 re-verifications since 2022-04-24, no change to tracked fields
Show 2 earlier versions
2021-02-19
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2020-04-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-01→confirmed 2020-02-23
Study sites0→1
2019-11-23
Original filing
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.
Trial Details
NCT Number NCT04178174
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: M.D. Anderson Cancer Center, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Jewish General Hospital
Conditions Head and Neck Cancer, Oropharynx Cancer, Human Papilloma Virus
Enrollment 360 participants
Start Date 2020-02-23
Primary Completion 2028-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-24