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Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

NCT01874587 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-07-27

No results posted yet for this study

Summary

The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference\>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

Conditions

  • Oropharynx Cancer

Interventions

RADIATION

adaptative radiotherapy

weekly replanning

Sponsors & Collaborators

  • Center Eugene Marquis

    lead OTHER

Principal Investigators

  • Renaud De Crevoisier, MD · Centre Eugène Marquis - Rennes - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-12-10
Completion
2020-12-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874587 on ClinicalTrials.gov