NCT05423704

Brief Summary

A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

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

May 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2026

Expected
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

June 7, 2022

Last Update Submit

June 15, 2022

Conditions

Head-and-neck Cancer

Keywords

Proton radiotherapy

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 2

    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 (7)

  • Loco-regional tumor control

    Up to five years after end of radiotherapy

  • Overall survival

    Up to five years after end of radiotherapy]

  • Acute toxicity

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

  • Late toxicity

    From two months to five years after end of radiotherapy]

  • EORTC QLQ-Head-Neck 35

    Up to five years after end of radiotherapy

  • +2 more secondary outcomes

Study Arms (1)

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

Other: Proton radiotherapy

Interventions

Proton radiotherapyOTHER

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

Proton 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 2 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, nasopharynx, unknown primary tumor and prior malignancies.
  • Patients with contraindications for proton therapy (as per 2019 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

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Danish Center for Particle Therapy

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group feasibility study
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 21, 2022

Study Start

May 20, 2019

Primary Completion

November 14, 2021

Study Completion (Estimated)

May 14, 2026

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

DK(7)