Locally advanced squamous cell cancers of the larynx or hypopharynx Cancer Larynx or hypopharynx cancer
Conditions
Interventions
The dose escalated IMRT (experimental) treatment group will receive 67.2 Gy in 28 fractions (2.4 Gy per fraction) to the involved site and nodal groups and 56 Gy in 28 fractions (2.0 Gy per fraction)
Sponsors
Royal Marsden NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or above, either sex 2. Histologically confirmed squamous cell cancer of the larynx or hypopharynx 3. Chemo-radiotherapy is the investigators treatment of choice. Induction chemotherapy is permitted. 4. Locally advanced squamous cell cancer of the larynx or hypopharynx i.e. stage III or IV a/b disease 5. World Health Organization (WHO) performance status of 0 or 1 6. Creatinine clearance of greater than 50 ml/min 7. Must be suitable to attend long term follow-up. All patients participating in the QoL study must have adequate cognitive ability to complete the QoL questionnaires. 8. Written informed consent Patients may undergo surgical biopsy or non-radical surgery prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Previous radiotherapy to the head and neck region 2. Clinical evidence of metastatic disease (Stage IVc) 3. Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment 4. Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy 5. Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer 6. Large primary tumour, where organ preservation is unrealistic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional failure free rate (LRFFR). Measured at 1, 2, 3, 4 and 8 weeks post-treatment and at 3, 6, 12, 18 and 24 months post treatment. Patients will then be followed up annually up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Laryngo-oesophageal dysfunction free rate 2. Overall survival (time from randomisation to death) 3. Acute and late toxicities following chemoradiation 4. Characteristics of patients who proceed to salvage neck dissection 5. Characteristics of patients who fail organ preservation All of the above will be measured at 1, 2, 3, 4 and 8 weeks post-treatment and at 3, 6, 12, 18 and 24 months post treatment. Patients will then be followed up annually up to 5 years. 6. Patient assessed quality of life, measured using questionnaires administered at baseline, end of radiotherpay treatment, 6 months, 1 year and then annually to 5 years post-treatment | — |
Countries
England, United Kingdom
Outcome results
None listed