Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer

Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer: a non randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44435485

Enrollment

Registered

2012-05-25

Start date

2012-11-02

Completion date

Unknown

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced squamous carcinoma of the oropharynx Cancer Malignant neoplasm of oropharynx

Interventions

Patients entered into the study will receive intensity modulated chemoradiotherapy (IMRT), 64Gy in 25F for 5 weeks. Chemotherapy (cisplatin) will also be given as standard practice once in the 1st wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven, P16 negative SCCOP deemed suitable for radical primary chemoradiotherapy with curative intent requiring bilateral neck irradiation. Neoadjuvant chemotherapy and pre or post chemoradiation neck dissections are permitted 2. Only patients requiring bilateral radiotherapy 3. Age =18 and 1,800 cells/mm3, platelets > 100,000 cells/mm3, haemoglobin > 8.0 g/dl 6. Creatinine clearance > 50 ml/minute 7. Informed consent

Exclusion criteria

Exclusion criteria: 1. Prior invasive malignancy (except basal cell carcinoma and cervical intraepithelial neoplasia) within last 3 years 2. Prior radiotherapy to the head and neck region 3. Pregnancy and/or lactation 4. Reproductive capability agreement to use contraceptive 5. Contraindications to cisplatin chemotherapy including active vascular disease (e.g. myocardial within last 6 months, angina and symptomatic peripheral vascular disease) 6. Non curative intent 7. Non squamous cell carcinoma histology 8. Nasophaynx, larynx, hypopharynx, salivary gland or sino-nasal primary site 9. Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent, follow up or determine the causality of adverse events 10. Suitable for unilateral radiotherapy

Design outcomes

Primary

Measure	Time frame
Full dose radiotherapy received as planned and the absence of consequential damage defined by the absence of Grade 3 mucositis at 3 months	—

Secondary

Measure	Time frame
1. Duration of Grade 3 mucositis: defined as the number of days of Grade 3 mucositis scored using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3 2. Incidence of acute Grade 4 toxicity defined according to the NCI CTCAE version 4 3. Incidence of = Grade 3 late toxicity defined according to RTOG (see appendix 2) and CTCAE version 4 scoring systems 4. Complete response rate at 3 months defined as no clinically visible (including endoscopic evaluation), palpable or measurable disease on imaging OR the absence of residual tumour on directed biopsy/neck dissection. The primary tumour and regional lymph nodes will be considered separately 5. Two year local control defined as no re-appearance of tumour within primary site (including immediately adjoining anatomical sites) or regional lymph nodes after complete response 6. Two year disease free survival defined in whole days, as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 7. Two year overall survival defined in whole days as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 8. Incidence of feeding tube dependency at one year defined by the patient requiring supplementation of nutrition by a feeding tube	—

Measure

Time frame

1. Duration of Grade 3 mucositis: defined as the number of days of Grade 3 mucositis scored using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3 2. Incidence of acute Grade 4 toxicity defined according to the NCI CTCAE version 4 3. Incidence of = Grade 3 late toxicity defined according to RTOG (see appendix 2) and CTCAE version 4 scoring systems 4. Complete response rate at 3 months defined as no clinically visible (including endoscopic evaluation), palpable or measurable disease on imaging OR the absence of residual tumour on directed biopsy/neck dissection. The primary tumour and regional lymph nodes will be considered separately 5. Two year local control defined as no re-appearance of tumour within primary site (including immediately adjoining anatomical sites) or regional lymph nodes after complete response 6. Two year disease free survival defined in whole days, as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 7. Two year overall survival defined in whole days as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 8. Incidence of feeding tube dependency at one year defined by the patient requiring supplementation of nutrition by a feeding tube

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026