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

October 18, 2020 updated by: Jens Overgaard, Danish Head and Neck Cancer Group

DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck

Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000 C
        • Recruiting
        • Department of Experimental Clinical Oncology, Aarhus University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with HART-CN
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole
Radiation: HART-CN
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional failure
Time Frame: Year 3
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).
Year 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Year 3
Death from all causes
Year 3
Acute radiation related morbidity
Time Frame: Month 3
Month 3
Late radiation related morbidity
Time Frame: Year 3
Year 3
Disease-specific death
Time Frame: Year 3
Disease-specific death is defined as death from or with the cancer in question;
Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Head and Neck Cancer Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAHANCA 33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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