NCT02976051

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

Status unknown Phase 2 Last updated 18 October 2020

What this trial tests

Phase 2 trial testing HART-CN in Locally Advanced Head and Neck Cancer in 60 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
1 June 2021

1 December 2022

Quick facts

Lead sponsor	Danish Head and Neck Cancer Group
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2017
Primary completion	1 June 2021
Estimated completion	1 December 2022
Sites	1 location across Denmark

Drugs / interventions tested

• HART-CN

Conditions studied

• Locally Advanced Head and Neck Cancer — all drugs for Locally Advanced Head and Neck Cancer →
• Radiotherapy — all drugs for Radiotherapy →
• Hypoxic Radioresistance — all drugs for Hypoxic Radioresistance →

Sponsor

Danish Head and Neck Cancer Group

Who can join

18 and older, any sex, with Locally Advanced Head and Neck Cancer or Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interfering with Tumor Hypoxia for Radiotherapy Optimization.
   Telarovic I, Wenger RH, Pruschy M. · · 2021 · cited 119× · PMID 34154610 · DOI 10.1186/s13046-021-02000-x
2. Hypoxia-activated prodrugs and (lack of) clinical progress: The need for hypoxia-based biomarker patient selection in phase III clinical trials.
   Spiegelberg L, Houben R, Niemans R, de Ruysscher D, et al · · 2019 · cited 85× · PMID 30734002 · DOI 10.1016/j.ctro.2019.01.005
3. Lattice or Oxygen-Guided Radiotherapy: What If They Converge? Possible Future Directions in the Era of Immunotherapy.
   Ferini G, Valenti V, Tripoli A, Illari SI, et al · · 2021 · cited 49× · PMID 34209192 · DOI 10.3390/cancers13133290
4. Functional Imaging of Hypoxia: PET and MRI.
   Perez RC, Kim D, Maxwell AWP, Camacho JC. · · 2023 · cited 18× · PMID 37444446 · DOI 10.3390/cancers15133336
5. DAHANCA 33: functional image-guided dose-escalated radiotherapy to patients with hypoxic squamous cell carcinoma of the head and neck (NCT02976051).
   Saksø M, Primdahl H, Johansen J, Nowicka-Matus K, et al · · 2020 · cited 12× · PMID 31805799 · DOI 10.1080/0284186x.2019.1695065
6. Targeting Hypoxia: Revival of Old Remedies.
   Vilaplana-Lopera N, Besh M, Moon EJ. · · 2021 · cited 9× · PMID 34827602 · DOI 10.3390/biom11111604
7. Prognostic and Predictive Biomarkers in Head and Neck Squamous Cell Carcinoma Treated with Radiotherapy-A Systematic Review.
   Schanne DH, Koch A, Elicin O, Giger R, et al · · 2022 · cited 6× · PMID 36552043 · DOI 10.3390/biomedicines10123288
8. Prognosis to Radiation Unlocked: How Hypoxia Methylome May Hold the Key in HNSCC.
   Heft Neal ME, Brenner JC. · · 2023 · cited 2× · PMID 37310809 · DOI 10.1158/1078-0432.ccr-23-1132