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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733823
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
HNSCC,Larynx, Pharynx and Oral Cavity Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
 Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Experimental: Group B
PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
 Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Experimental: Group C
PS 0-1 Charlson >=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
 Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Experimental: Group D
PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
 Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733823


Locations
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Denmark
Aarhus
Aarhus, Aarhus C, Denmark, 8000
Odense
Odense, Odense C, Denmark, 5000
Aalborg
Aalborg, Denmark, 9100
Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
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Principal Investigator: Jens Overgaard, MD, DMSc Danish Head and Neck Cancer Group
More Information
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Responsible Party: Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01733823    
Other Study ID Numbers: DAHANCA 28A
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Nimorazole
 Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents