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Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole (DAHANCA28A)

This study is not yet open for participant recruitment.
Verified November 2012 by Danish Head and Neck Cancer Group
Sponsor:
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT01733823
First received: November 8, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
P16 Negative SCC Head and Neck Cancer of the 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Danish Head and Neck Cancer Group:

Primary Outcome Measures:
  • Compliance [ Time Frame: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy) ] [ Designated as safety issue: Yes ]
    Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time


Secondary Outcome Measures:
  • Acute toxicity [ Time Frame: 2 months after end of radiotherapy ] [ Designated as safety issue: Yes ]
    In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales

  • Response rate [ Time Frame: 2 months after end of radiotherapy ] [ Designated as safety issue: No ]
    Proportion of complete and partial responders


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733823

Contacts
Contact: Jens Overgaard, DrMSc +45 78462620 jens@oncology.dk
Contact: Kenneth Jensen, PhD +45 78460000 kennjens@rm.dk

Locations
Denmark
Aarhus Not yet recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Kenneth Jensen, PhD     +45 78460000     kennjens@rm.dk    
Principal Investigator: Kenneth Jensen, PhD            
Odense Not yet recruiting
Odense, Odense C, Denmark, 5000
Contact: Jesper Grau Eriksen, PhD            
Principal Investigator: Jesper Grau Eriksen, PhD            
Aalborg Not yet recruiting
Aalborg, Denmark, 9100
Contact: Lisbeth Juhler Andersen, MD            
Principal Investigator: Lisbeth Juhler Andersen, MD            
Herlev Not yet recruiting
Herlev, Denmark, 2730
Contact: Elo ANdersen, MD            
Principal Investigator: Elo Andersen, MD            
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
Principal Investigator: Jens Overgaard, DrMSc Danish Head and Neck Cancer Group
  More Information

No publications provided

Responsible Party: Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01733823     History of Changes
Other Study ID Numbers: DAHANCA 28A
Study First Received: November 8, 2012
Last Updated: November 27, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Laryngeal Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Cisplatin
Nimorazole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013