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Parotid sparing adaptive radiotherapy in head and neck cancer.

Parotid sparing adaptive radiotherapy in Head and Neck cancers - a randomized controlled trial - PARITY2

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052216
Enrollment
300
Registered
2023-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: C32- Malignant neoplasm of larynx Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Adaptive Radiation Therapy: Patients who have a parotid dose increase during treatment will have a new adaptive radiotherapy plan implemented between 14-18 fractions and continued till

Sponsors

Tata Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pathologically proven squamous cell carcinomas of head and neck including oral cavity, oropharynx, hypopharynx, larynx and nasopharynx. Age between 18 â?? 80 years Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Undergoing radical or adjuvant radiation/chemoradiation and requiring bilateral neck irradiation. One or both parotids are intended to receive at least a dose between 25 â?? 30 Gy in the initial plan.

Exclusion criteria

Exclusion criteria: Prior surgery of the parotid glands Prior radiation therapy to the head and neck region. Prior cytotoxic chemotherapy Poor candidates for regular post-treatment surveillance.

Design outcomes

Primary

MeasureTime frame
Mean XeQoLS score changes with time between the armsTimepoint: end of treatment, 3 months, 6 months, 9 months and 12 months

Secondary

MeasureTime frame
Disease free survivalTimepoint: Median and 2-year;Mean EORTC QLQ C30 and HN35 global quality of life, functioning and symptom burden scale changes with time between arms. Timepoint: at multiple visits done between end of RT and 12 months;Mean XeQoLS domain scores for xerostomia related physical functioning, pain or discomfort, personal / psychological functioning and social functioning changes with time between arms Timepoint: at multiple visits between end of RT and 12 months;Overall survivalTimepoint: Median and 2-year

Countries

India

Contacts

Public ContactDr Sanjoy Chatterjee

Tata Medical Center

sanjoy.chatterjee@tmckolkata.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026