Dose Escalation Versus Standard in Laryngopharyngeal Cancers (INTELHOPE)
Malignant Neoplasm of Oropharynx Stage III, Malignant Neoplasm of Larynx Stage III, Malignant Neoplasm of Hypopharynx Stage III
About this trial
This is an interventional treatment trial for Malignant Neoplasm of Oropharynx Stage III
Eligibility Criteria
LH Inclusion Criteria ALL of the following inclusion criteria must be met
- Histologically confirmed squamous cell cancer of the larynx or hypopharynx
- Radiotherapy with concomitant chemotherapy as primary therapy
- Induction chemotherapy is permitted
- TNM Stage T3-4, N0-3, M0 or T1/2 with N2-3 disease (Stage III or IV a/b) disease
- WHO performance status of 0 or 1
- Creatinine clearance of more than 50ml/min
- All patients must be suitable to attend regular follow up
OPC inclusion criteria ALL of the following inclusion criteria must be met
- Histologically confirmed squamous cell cancer of the oropharynx
- Radiotherapy with concomitant chemotherapy as primary therapy
- Induction chemotherapy is permitted
- WHO performance status of 0 or 1
- Creatinine clearance of more than 50ml/min
- All patients must be suitable to attend regular follow up
- And any of the stage of disease as seen below HPV (p16) negative: TNM Stage T2-T4, any N stage, M0 disease HPV (p16) Positive: more than 10 pack year history and N2b or N3 disease
LH Exclusion Criteria The patient is ineligible if ANYONE of the following exclusion criteria is met
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment
- Previous or concurrent illness, which in the investigator's opinion would interfere with either completion of therapy or follow-up
- Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer
- Patients with locally advanced LH tumours where organ preservation is unrealistic
- Patients with metastatic carcinoma
OPC Exclusion Criteria The patient is ineligible if ANYONE of the following exclusion criteria is met
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment
- Previous or concurrent illness, which in the investigator's opinion would interfere with either completion of therapy or follow-up
- Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer
- Patients with locally advanced LH or OPC tumours where organ preservation is unrealistic
- Patients with metastatic carcinoma
- Low risk OPC: HPV p16 positive T1-2 with N0-N2a disease or less than 10 pack year history
Sites / Locations
- Tata Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard dose
Escalated dose
Patients receive a radiation dose of 66Gy in 30 fractions to the planning target volume 1 (PTV1) and 54 Gy in 30 fractions to the PTV2 concurrent with platinum chemotherapy weekly
Patients receive a radiation dose of 73.5 Gy in 30 fractions to the boost target volume (BTV), 63Gy in 30 fractions to PTV1 and 54 Gy in 30 fractions to PTV2 concurrent with platinum chemotherapy weekly