Health Condition 1: C119- Malignant neoplasm of nasopharynx,unspecified
Conditions
Interventions
Intervention1: Intensity Modulated Proton Therapy: IMPT is a sophisticated type of proton therapy used in cancer treatment, similar to Intensity-Modulated Radiation Therapy (IMRT). It allows for preci
Sponsors
Tata Memorial Centre Research Administration Council
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with histopathologically confirmed NPC: squamous, undifferentiated or poorly differentiated carcinoma 2.Age more than or equal to 18 years 3.Stage II-IVA NPC (as per the 8th AJCC staging) 4.Planned for treatment with curative intent 5.Willing to undergo treatment at TMC Proton Therapy Centre 6.Willing to give informed consent 7.Patients who have received standard neoadjuvant chemotherapy outside/TMH and have a baseline pre-treatment imaging and staging information available
Exclusion criteria
Exclusion criteria: 1.Patients with oligometastatic or metastatic disease 2.Other nasopharyngeal histopathologies like sarcomas, adenocarcinoma, lymphoma etc. 3.Significant comorbidities precluding combined modality treatment with chemotherapy and/or radiotherapy 4.Patients with synchronous or metachronous primary 5.Patients who have received prior RT to the head and neck region 6.Patients with pre-existing significant salivary gland pathology 7.Incompletely or partially treated NPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) and overall survival (OS)Timepoint: Progression-free survival (PFS) and overall survival (OS) at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess patient reported xerostomia and hearing loss post treatment in both the arms Timepoint: baseline, RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion;Objective evaluation of xerostomia using salivary scintigraphy post RT in both the armsTimepoint: baseline, 3 months, 6 months, 1 year and 2 years post RT completion;Comparison of other radiation-related acute- and late-toxicities in both the arms Timepoint: evaluated on treatment, at conclusion, 3 months, 6 months, 1 year and 2 years post RT completion;To assess Quality of Life (QoL) in both the armsTimepoint: baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion.;To assess the cost effectiveness of IMPT over IMRTTimepoint: baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion. | — |
Countries
India
Contacts
Public ContactDr Sarbani Ghosh Laskar
Tata Memorial Hospital
Outcome results
None listed