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

NCT ID: NCT02976051

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Locally Advanced Head and Neck Cancer Radiotherapy Hypoxic Radioresistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with HART-CN

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

Group Type EXPERIMENTAL

HART-CN

Intervention Type RADIATION

HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole

Interventions

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HART-CN

HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Head and Neck Cancer Group

NETWORK

Sponsor Role lead

Responsible Party

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Jens Overgaard

Professor, MD DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens Overgaard, MD, DMSc

Role: CONTACT

+45 78462629

Mette Saksoe, MD

Role: CONTACT

+45 78462629

Facility Contacts

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Jens Overgaard, Prof., MD

Role: primary

+45 7846 2629

Mette Saxø, MD

Role: backup

+89492619

References

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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.

Reference Type RESULT
PMID: 23083497 (View on PubMed)

Other Identifiers

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DAHANCA 33

Identifier Type: -

Identifier Source: org_study_id

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