Analyzing the feasibility and benefit of Hippocampus sparing in Head and Neck cancer radiotherapy.

RANDOMISED CONTROLLED TRIAL ANALYSING DOSIMETRY AND NEUROCOGNITIVE OUTCOMES OF HIPPOCAMPAL SPARING RADIOTHERAPY IN HEAD AND NECK CANCERS - HipART-HN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054417

Enrollment

Registered

2023-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: C300- Malignant neoplasm of nasal cavity Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: C696- Malignant neoplasm of orbit

Interventions

Intervention1: Hippocampal Sparing Radiotherapy: All patients will be treated with 2-3 planning target volumes [PTV]- High risk and Low-risk PTVs [Intermediate risk PTVs, if needed], among which the h

Eligibility

Inclusion criteria

Inclusion criteria: - Head and neck Squamous or Adeno carcinoma post-operative with PTV involving high masticator space or high infratemporal fossa or nasal cavity or paranasal sinuses planned for adjuvant radiotherapy with or without concurrent chemotherapy with equivalent prescription doses in the range of 60-66 Gy (depending on margin status). - Cancers of the nasopharynx or nasal cavity or paranasal sinuses or orbit planned for definitive radiotherapy with or without concurrent chemotherapy with equivalent prescription doses above 66-70Gy - Age: 18-75years - ECOG: 0-2 - Non-Metastatic disease - Curative Intent of treatment

Exclusion criteria

Exclusion criteria: - Prior Radiotherapy to Head and Neck region/ Brain - Gross tumor volume in the hippocampal region or within a 5mm margin around the hippocampus - Previous or present history of neurological diseases or syndromes - Pregnant or Lactating women - Blindness - Contraindications to MR imaging such as Implanted Metal devices or foreign bodies, severe claustrophobia - Co-existing surgical or medical conditions precluding the use of Radical/Adjuvant RT/CTRT.

Design outcomes

Primary

Measure	Time frame
Dosimetric differences between hippocampal sparing & non-hippocampal sparing radiotherapy in patients of head & neck cancersTimepoint: Radiotherapy Planning before Radiotherapy Treatment	—

Secondary

Measure	Time frame
Neurocognitive function measured by ADDENBROOKE’S COGNITIVE EXAMINATION – ACE-IIITimepoint: 3- & 6-months post radiotherapy follow-up;Acute toxicities as per RTOG criteria will be recordedTimepoint: During Radiotherapy & 1 & 3 months post radiotherapy treatment	—

Countries

India

Contacts

Public ContactDr NARAPAREDDY VENKATA DINESH REDDY

Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi

drashutoshm@gmail.com9489146747

Outcome results

None listed

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