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PRONTONCT06421649

Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 1 year 3 months later.

See at-risk trials from The Christie NHS Foundation Trust

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Sep 1, 2029 Show 7 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Nov 1, 2024 to Sep 5, 2025
    • Eligibility criteria expanded, about 14 words
    • Study sites: 0 to 2
    • Secondary endpoints: details revised at 3 of 12 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Start date: Jun 1, 2024 to Nov 1, 2024
    • Primary completion date: Jan 1, 2028 to Jun 1, 2028
    • Study completion date: Jan 1, 2029 to Jun 1, 2029
    v3
  3. Secondary endpoints revised (12)v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Taste dysfunction
Timeframe: 12 months

Secondary (12)

Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades
Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale
Clinician reported acute and late toxicity - measurement of hearing changes
Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire
Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Head & Neck 43 (HN43) patient reported questionnaire.
Show 7 moreShow less
Patient reported acute and late toxicity using University of Washington Quality of Life (UW-QoL) questionnaire
Patient reported acute and late toxicity using Glasgow hearing Aid Benefit Profile (GHABP) questionnaire
Loco-regional tumour control
Overall survival
Patient participation in the study each year
Study completion rates
Oral cavity radiation dose

Arms and interventions

Proton Beam TherapyExperimental

All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.

Radiation: Proton Beam Therapy

Sites

2 sites in 1 country