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Parotid Sparing Adaptive Radiotherapy

Parotid Sparing Adaptive Radiotherapy in Head and Neck Cancer Patients â?? A Study Evaluating the Resource Intensiveness and Impact on Quality Of Life - PARITY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010683
Enrollment
90
Registered
2017-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Squamous cell carcinoma of the Head and Neck

Interventions

Intervention1: Adaptive Radiotherapy: Adaptive radiotherapy is done for the patient if the dose to the parotids are increased during radiation as per the protocol specifications Control Intervention1:

Sponsors

Tata Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathologically proven squamous cell carcinomas of head and neck including oropharynx, hypopharynx, larynx and nasopharynx. History and physical examination prior to the start of the treatment. For those undergoing radical treatment physical examination should have been done as recent as two weeks prior to the start of the treatment. CT of the Head and Neck region, CT Chest to be done as part of the staging protocol. 2. Age between 18 â?? 70 years 3. ECOG 0 or 1 4. Undergoing radical or adjuvant radiation/chemoradiation and requires bilateral neck irradiation. 5. One or both parotids are intended to receive at least a dose between 25 â?? 30 Gy in the initial plan. No exceptions to the eligibility criteria are permitted.

Exclusion criteria

Exclusion criteria: 1. Prior surgery of the parotid glands 2. Prior radiation therapy to the head and neck region. 3. Prior cytotoxic chemotherapy 4. Patients having xerostomia as per the pre radiotherapy evaluation 5. Both the parotids are receiving more than 50 Gy in the initial plan. 6. Patients with distant metastases. 7. Unlikely to be on follow up with us after completion of radiotherapy.

Design outcomes

Primary

MeasureTime frame
To calculate the person hours for Adaptive Radiotherapy for those undergoing the same on Helical Tomotherapy and Rapidarc compare it with the person hours calculated for standard IMRT techniquesTimepoint: Weekly assessment during treatment QOL assessment at pre-treatment, 3 months post-treatment and 9-months post-treatment

Secondary

MeasureTime frame
Assessing the anxiety and the depression of the patients using Hospital Anxiety and Depression Scale (HADS).Timepoint: Baseline, at 3 months and at 9 months of follow up;Quality of Life assessment for all patients undergoing conventional Intensity Modulated radiation therapy or adaptive Radiotherapy using EORTC QLQ C30 and QLQ HN 35. Timepoint: Baseline, at 3 months and at 9 months of follow up;Xerostomia assessment of all patients using xerostomia-related quality of life scale (XeQoLS). Timepoint: Baseline, at 3 months and at 9 months of follow up

Countries

India

Contacts

Public ContactMoses Arunsingh

Tata Medical centre

moses.arunsingh@tmckolkata.com09007395797

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026