NCT04607694

Brief Summary

Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

October 19, 2020

Last Update Submit

October 23, 2020

Conditions

Head-and-neck Cancer

Keywords

Proton radiotherapyDAHANCA

Outcome Measures

Primary Outcomes (2)

  • Dysphagia >= grade 2

    The rate of observer-reported dysphagia \>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best)

    Six months after end of radiotherapy

  • Xerostomia = grade 4

    The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)

    Six months after end of radiotherapy

Secondary Outcomes (13)

  • Loco-regional tumor control

    Up to five years after end of radiotherapy

  • Overall survival

    Up to five years after end of radiotherapy

  • Number of participants with disease-free survival

    Up to five years after end of radiotherapy

  • Disease-specific survival

    Up to five years after end of radiotherapy

  • Acute toxicity

    From the beginning of and up to two months after end of radiotherapy

  • +8 more secondary outcomes

Study Arms (2)

Proton radiotherapy

EXPERIMENTAL

Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients

Radiation: Proton radiotherapy

Photon radiotherapy

ACTIVE COMPARATOR

Photon radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients

Radiation: Photon radiotherapy

Interventions

Proton radiotherapyRADIATION

Proton radiotherapy

Proton radiotherapy
Photon radiotherapyRADIATION

Photon radiotherapy

Photon radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
  • A predicted clinical significant reduction in the risk of any of the two primary endpoints (\>= grade 2 observer-rated dysphagia or grade 4 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
  • No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
  • Informed consent as required by law
  • Above 18 years of age

You may not qualify if:

  • Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, unknown primary tumor and prior malignancies.
  • Patients with contraindications for proton therapy. Per October 2020, this includes pacemakers, implanted defibrillators and tracheostomy
  • Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
  • Distant metastasis
  • Previous radiotherapy of the head and neck
  • Previous surgery for the primary cancer with curative intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Danish Center for Particle Therapy

Aarhus, Denmark

RECRUITING

Herlev Hospital

Copenhagen, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Næstved Hospital

Næstved, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Jeppe Friborg, MD, PhD

    Danish Head-Neck Cancer Group (DAHANCA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeppe Friborg, MD, PhD

CONTACT

+45 35458189jeppe.friborg@regionh.dk

Kenneth Jensen, MD, PhD

CONTACT

+45 78456400kennjens@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 29, 2020

Study Start

October 9, 2020

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(7)