Adaptive Radiotherapy for Head and Neck Cancer: Feasibility and Clinical Implications

Phase 2

• Conditions: Head and Neck Cancer; Cancer - Head and neck

• Registration Number: ACTRN12615000771550
• Lead Sponsor: Susan Mincham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 18 years or above
- Histologically proven squamous cell carcinoma of the head and neck region (oropharynx, nasopharynx, hypopharynx, larynx)
- Locally advanced disease (AJCC Stage III/IV)
- Multidisciplinary decision to treat with curative intent definitive radiation or chemoradiation using Image-guided IMRT/VMAT
- ECOG 0-2
- Able to give informed consent

Exclusion Criteria

- Definitive surgery to primary tumour or nodal disease
- Neoadjuvant chemotherapy
- Prior radiotherapy or chemotherapy
- Previous malignancy (except treated cutaneous skin cancers)
- Pregnant or breastfeeding women
- Both parotid glands entirely within the target volume (unable to achieve parotid sparing)
- Contraindications to radiotherapy (e.g. radiosensitivity syndromes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose to organs at risk (salivary glands, mandible, spinal cord) as predicted using the radiotherapy treatment planning system and dose accumulation method for the adaptive plans.<br><br>[On completion of radiotherapy treatment, approximately 7 weeks.];Dose to Planning Target Volume as predicted using the radiotherapy treatment planning system and dose accumulation method for the adaptive plans.<br><br>The maximum dose, minimum dose, mean dose, D98% (dose to 98% of the volume), D2% (dose to 2% of the volume) and a dose-volume histogram are automatically calculated and recorded by the radiotherapy treatment planning system from the radiotherapy planning CT.[On completion of radiotherapy treatment, approximately 7 weeks.]

Secondary Outcome Measures

Name	Time	Method
Time (hours) taken for all re-planning. <br>The time taken for re-contouring will be recorded for each participant by the PI performing the contouring, and an estimate of the time taken for the radiation therapists to re-plan the treatment will be added to this for each re-plan.[On completion of radiotherapy treatment (approximately 7 weeks)]