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Completed

NCT Number: NCT01733823

DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification

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Key information

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Respiratory Tract Diseases Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aarhus, Aarhus C, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
  • P16 negative
  • T1-4
  • N1-3
  • M0
  • Organ function and performance status allowing radical chemo-radiotherapy

Exclusion criteria

  • None

Treatment and study plan

76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Radiation

Primary outcomes

  1. Compliance

    Time frame: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)

    Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time

Secondary outcomes

  1. Acute toxicity

    Time frame: 2 months after end of radiotherapy

    In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales

  2. Response rate

    Time frame: 2 months after end of radiotherapy

    Proportion of complete and partial responders

Sponsors and collaborators

Lead sponsor

Danish Head and Neck Cancer Group

Network

Registry information

Official study title

Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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