A phase III trial of intensity-modulated proton beam therapy versus intensity-modulated radiotherapy for multi-toxicity reduction in oropharyngeal cancer

Phase 3

• Conditions: Oropharyngeal cancer; Cancer; Malignant neoplasm of oropharynx

• Registration Number: ISRCTN16424014
• Lead Sponsor: Institute of Cancer Research

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36452431/ (added 29/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-27
• Last Update Posted: 16 January 2023
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. Histologically confirmed oropharyngeal squamous cell carcinoma
2. HPV positive TNM8: T1-2 N1-2 (excluding T1-2 with a single ipsilateral node < 3cm), T3-4 N0-2
3. HPV negative TNM 8: T1N2, T2N1-N2, T3-4N0-2
4. Local MDT decision for concurrent chemoradiotherapy with bilateral neck treatment
5. Age > = 18 years
6. WHO performance status 0-1
7. Adequate renal function, glomerular filtration rate (GFR) > 60ml/min calculated using Cockcroft-Gault formula
8. Adequate cognitive ability (in the opinion of the local PI) to complete PRO assessments
9. Willingness to comply with the protocol, including travel to the proton centre for IMPT treatment
10. Written informed consent

Exclusion Criteria

1. Feeding tube insertion required for nutrition due to dysphagia prior to treatment [Note: patients who have prophylactic feeding tube insertion, with or without tube use to top up nutrition prior to starting treatment, remain eligible for the study]
2. N3 disease
3. Upfront neck dissection
4. Use of induction chemotherapy
5. Previous head and neck radiotherapy
6. Major surgery within 6 months of trial entry
7. Permanent pacemaker or implantable cardioverter-defibrillator
8. Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ)
9. Previous or concurrent illness (e.g., active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis), which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up
10. Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active)
11. Pre-existing speech or swallowing problems unrelated to the diagnosis of cancer

For patients taking part in the optional DW-MRI study at The Christie Hospital the following additional exclusion criteria apply:
1. Any contraindication to MRI scanning, including metallic heart valve replacement, permanent pacemaker, implantable cardiac defibrillator, non-MRI compatible metal implants, neuro-stimulators
2. A history of allergy/reaction to Gadolinium contrast

Study & Design

• Study Type: Interventional
• Study Design: Not specified