Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

NCT04178174 | Recruiting Phase 3 DMC

• 1 other identifier: SHORT-OPC
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Cancer; Oropharynx Cancer; Human Papilloma Virus

Keywords

head and neck cander; Oropharynx cancer; Human papilloma virus; Radiotherapy; Stereotactic body radiotherapy; Chemotherapy; De-intensification

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation

  2 years after the end of chemoradiation

Secondary Outcomes (8)

• Subacute toxicity

  Between 2 and 6 months after the end of chemoradiation

• Acute toxicity

  Less than 2 months after the end of chemoradiation

• Late toxicity

  Between 6 months and 5-years after the end of chemoradiation

• OS

  At 2- and 5-years after the end of chemoradiation

• locoregional control

  At 2- and 5-years after the end of chemoradiation

Study Arms (2)

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.

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.

Radiation: Standard chemoradiation

Interventions

SABR boost and de-escalated chemoradiation RADIATION

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

SABR boost and de-escalated chemoradiation

Standard chemoradiation RADIATION

Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions

Standard chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Primary tumor \< 30 cc
• Planned for curative chemoradiation
• For females of child-bearing age, a negative pregnancy test

You may not qualify if:

• 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
• Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
• Non-Cisplatin concurrent chemotherapy
• Prior induction chemotherapy

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• M.D. Anderson Cancer Center: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• Jewish General Hospital: collaborator

Study Sites (2)

London Health Sciences Center

London, Ontario, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 1R6, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Houda Bahig, MD PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

• Phuc-Felix Nguyen-Tan, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

• David Palma, MD PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

• Jack Phan, MD PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Khalil Sultanem, MD

  Montreal Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Trudel

CONTACT

514-890-8254; diane.dt.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 26, 2019
• Study Start: February 23, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)