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NCT02201355

Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck

Terminated Phase 1 Last updated 2 February 2021
What this trial tests

Phase 1 trial testing Intensity Modulated Radiotherapy in Squamous Cell Carcinoma of the Head and Neck T1/2N0-2 in 8 participants. Terminated before completion.

Timeline
18 September 2014
Primary endpoint
23 January 2018
15 May 2020

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date18 September 2014
Primary completion23 January 2018
Estimated completion15 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 99, any sex, with Squamous Cell Carcinoma of the Head and Neck T1/2N0-2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objectives: To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT Secondary Objectives: To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation. To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation. To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation. If patients can safely be treated in three weeks rather than six weeks, such a schedule would provide a much more convenient alternative for patients and result in a significant reduction in the health care resources currently expended on cure of these patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Intensity Modulated Radiotherapy

Trials testing the same drug.

Other University of Texas Southwestern Medical Center trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02201355.

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