CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 90 target
Drug / intervention
Radiotherapy to all dissected areas +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 3
  • Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck dissection
  • Pathological features indicating need for postoperative radiotherapy: positive or close margin, LVI or PNU, pT3/pT4 disease, positive lymph nodes
  • Pathologically lymph node negative in at least one dissected hemi-neck with at least 10 nodes recovered
Key exclusion· 10
  • Prior head and neck radiation at any time
  • Prior oncologic head and neck surgery in the oral cavity or neck
  • Prior history of head and neck cancer within 5 years
  • Any other active invasive malignancy except non-melanotic skin cancers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03997643
NCT03997643Phase 2RecruitingHigh MomentumUpdated 34mo ago
Long Recruiting

Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial

In Brief

A Phase 2 clinical trial evaluating Radiotherapy to all dissected areas and Omit radiation to pN0 neck for Head and Neck Cancer. Currently recruiting, targeting 90 participants across 8 sites in 4 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Ireland, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
2020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartSep 6, 2019
Primary CompletionSep 1, 2026
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 7.0 years agoPrimary completion in 2 months

Interventions

Radiotherapy to all dissected areasradiation

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

Omit radiation to pN0 neckradiation

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