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Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC

NCT01864850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-09-22

No results posted yet for this study

Summary

Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.

Conditions

Interventions

RADIATION

Standard RT

70 Gy / 7 weeks / 2 Gy per fraction

RADIATION

Hypofractionated RT

55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-18
Primary Completion
2020-06-30
Completion
2020-06-05

Countries

  • France
  • Monaco

Study Locations

More Related Trials

Entities

Diseases

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 NCT01864850 on ClinicalTrials.gov