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DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

Primary Purpose

Locally Advanced Head and Neck Cancer, Radiotherapy, Hypoxic Radioresistance

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
HART-CN
Sponsored by
Danish Head and Neck Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage III-IV larynx, pharynx, oral cavity
  • Hypoxic FAZA-PET positive
  • Indication for primary radio-chemotherapy
  • Informed consent

Exclusion Criteria:

  • HPV positive oropharynx cancer
  • Primary surgery

Sites / Locations

  • Department of Experimental Clinical Oncology, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with HART-CN

Arm Description

HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole

Outcomes

Primary Outcome Measures

Loco-regional failure
loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).

Secondary Outcome Measures

Overall survival
Death from all causes
Acute radiation related morbidity
Late radiation related morbidity
Disease-specific death
Disease-specific death is defined as death from or with the cancer in question;

Full Information

First Posted
November 22, 2016
Last Updated
October 18, 2020
Sponsor
Danish Head and Neck Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT02976051
Brief Title
DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC
Official Title
DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Head and Neck Cancer Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
Detailed Description
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET. Inclusion: Patients must fulfill the following: Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Head and Neck Cancer, Radiotherapy, Hypoxic Radioresistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with HART-CN
Arm Type
Experimental
Arm Description
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole
Intervention Type
Radiation
Intervention Name(s)
HART-CN
Intervention Description
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole
Primary Outcome Measure Information:
Title
Loco-regional failure
Description
loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Overall survival
Description
Death from all causes
Time Frame
Year 3
Title
Acute radiation related morbidity
Time Frame
Month 3
Title
Late radiation related morbidity
Time Frame
Year 3
Title
Disease-specific death
Description
Disease-specific death is defined as death from or with the cancer in question;
Time Frame
Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage III-IV larynx, pharynx, oral cavity Hypoxic FAZA-PET positive Indication for primary radio-chemotherapy Informed consent Exclusion Criteria: HPV positive oropharynx cancer Primary surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Overgaard, MD, DMSc
Phone
+45 78462629
Email
jens@oncology.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Saksoe, MD
Phone
+45 78462629
Email
mette.saksoe@oncology.au.dk
Facility Information:
Facility Name
Department of Experimental Clinical Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Overgaard, Prof., MD
Phone
+45 7846 2629
Email
jens@oncology.au.dk
First Name & Middle Initial & Last Name & Degree
Mette Saxø, MD
Phone
+89492619
Email
mette.saksoe@oncology.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23083497
Citation
Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.
Results Reference
result

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DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

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