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

This study is currently recruiting participants.
Verified November 2013 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 1, 2013
Last verified: November 2013
  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
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 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:


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 Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Kenneth Jensen, PhD    +45 78460000    kennjens@rm.dk   
Principal Investigator: Kenneth Jensen, PhD         
Odense Recruiting
Odense, Odense C, Denmark, 5000
Contact: Jesper Grau Eriksen, PhD         
Principal Investigator: Jesper Grau Eriksen, PhD         
Aalborg Recruiting
Aalborg, Denmark, 9100
Contact: Lisbeth Juhler Andersen, MD         
Principal Investigator: Lisbeth Juhler Andersen, MD         
Herlev 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 1, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 April 17, 2014