Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C13- Malignant neoplasm of hypopharynx Health Condition 3: C10- Malignant neoplasm of oropharynx Health Condition 4: C12- Malignant neoplasm of pyriform sinus Health Condition 5: C09- Malignant neoplasm of tonsil
Conditions
Interventions
Intervention1: Induction Chemotherapy and Dysphagia Optimized Intensity Modulated Radiotherapy (DO-IMRT): Induction chemotherapy of physician choice for 2-3 cycles every 3 weekly will be given as per
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx. 3.Patients with tumor at other sites where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible 4.Stage T1-4,N03,M0 disease; 5. this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types may be eligible. 6. Radiotherapy with concomitant chemotherapy (unless contra-indicated) is the planned treatment 7.WHO performance status 0 or 1 8. Must be available to attend long term follow up 9.Adequate cognitive ability to complete the questionnaires 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer). 2.Previous radiotherapy to the head and neck region. 3.Any contra-indication to Chemotherapy/Radiotherapy 4.Posterior pharyngeal wall, post cricoid or retropharyngeal lymph node involvement. 5.Lateralized tumors, requiring unilateral neck irradiation. 6.Major head and neck surgery (excluding biopsies/tonsillectomy). 7.Current/previous tracheostomy placement. 8.Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up. 9.Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine, if using induction chemotherapy and dysphagia optimized IMRT (DO-IMRT) to reduce the radiation dose delivered to the dysphagia/aspiration related structures (DARS), improves swallowing function in patients with head and neck cancer treated with radical radiotherapy or chemoradiation.Timepoint: weekly assessment during RT delievery and thereafter 0,1,3,6 months post RT completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence rate Locoregional recurrence rate (LRR) Disease free survival (DFS) Disease metastases free survival (DMFS) Overall survival (OS) Disease specific survival (DSS) Measurement of the quality of life (QOL) Assessment of treatment-related toxicity measured by the physicians using standardized common toxicity criteria for adverse events CTCAE, version 5.0 Acute radiation Toxicity (CTCAE 5.0, Pre RT, Post RT) Comparison of Doses to critical structures Association of outcomes with HPV statusTimepoint: weekly assessment during RT delievery and thereafter 0,1,3,6 months post RT completion | — |
Countries
India
Contacts
Public ContactDr Puneet Pareek
AIIMS Jodhpur
Outcome results
None listed