Recruiting
Phase 2

Radiation Volume Effects

Sponsor:

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

Code:

NCT03997643

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy to all dissected areas

Omit radiation to pN0 neck

Study Details

Brief summary:

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

Conditions

Head and Neck Cancer

Study ID

NCT03997643

Start date

Sep 6, 2019

Status verified date

Aug, 2023

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing to provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection
  • Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician
  • Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck

Exclusion Criteria:

  • Serious medical comorbidities or other contraindications to radiotherapy
  • Prior history of head and neck cancer within 5 years
  • Any other active invasive malignancy, except non-melanotic skin cancers
  • Prior head and neck radiation at any time
  • Prior oncologic head and neck surgery in the oral cavity or neck
  • Metastatic disease
  • Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy
  • Inability to attend full course of radio therapy or follow-up visits
  • Unable or unwilling to complete QoL questionnaires
  • Pregnant or lactating women

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Radiotherapy

Radiotherapy to all dissected areas

experimental: Radiotherapy to smaller treatment area

Omit radiation to pN0 neck

Interventions

Radiotherapy to all dissected areas

Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

Omit radiation to pN0 neck

post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

Primary outcome measure

  • Regional failure in the pN0 hemi-neck (s) [ Time Frame: Baseline to 5 years ]

Central Contacts and Locations

Locations

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33143

Contacts

Noah Kalman, MD

786-596-2000NoahK@baptisthealth.net

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Pencilla Lang, MD

519-685-8500Pencilla.Lang@lhsc.on.ca

Laura Bailey

519-685-8618LauraD.Bailey@lhsc.on.ca

CHUM

Recruiting

Montréal, Quebec, Canada, H2X 0A9

Contacts

Houda Bahig, MD

5148908000houda.bahig.chum@ssss.gouv.qc.ca

More Information

Sponsor

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

Last update posted

Aug 3, 2023

Last verified

Aug, 2023

Keywords

  • Radiation Therapy
  • Oral Cavity Squamous Cell Carcinoma
  • Randomized Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-08-03.