CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
chemotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03067610
NCT03067610Phase 2Completed
CompareCT.gov

A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy

University of Texas Southwestern Medical Center·interventional·Posted Mar 1, 2017·Updated Mar 17, 2022

In Brief

A Phase 2 clinical trial evaluating Intensity Modulated Radiation Therapy and chemotherapy for Head and Neck Cancer and 3 related conditions. Completed, enrolled 72 participants across 2 sites.

Detailed Summary

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Carcinoma, Squamous Cell, Neoplasms, Oral, Neoplasms, Pharyngeal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 1, 2017
Enrollment StartJan 20, 2017
Primary CompletionDec 21, 2020
Study CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.3 years ago

Interventions

Intensity Modulated Radiation Therapyradiation

The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.

chemotherapydrug

chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion