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

Phase 2

Completed

Conditions: Malignant neoplasm of nasal cavity, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C696||Malignant neoplasm of orbit,

Brief Summary: Head and Neck cancers are one of the most common cancers in many developing countries like India. The mainstay of treatment for loco-regionally advanced head and neck cancer is either surgery followed by adjuvant radiation therapy or definitive radiotherapy with/ without concurrent chemotherapy. In radiotherapy in head and neck malignancies, the hippocampus has not been conventionally considered as a organ-at risk and has not been delineated and spared.

In radiotherapy to the brain in case of CNS malignancies, recent evidence has demonstrated the effectiveness of hippocampal sparing in reducing radiation-related cognitive decline and QoL, using more conformal techniques like Intensity Modulated Radiotherapy [IMRT], Volumetric Modulated Arc Therapy [VMAT], and Proton Therapy. Recent dosimetric studies have established that the hippocampus dose in routine head and neck radiotherapy is often significant and may potentially lead to hippocampal toxicities.

This trial aims to firstly dosimetrically study the hippocampal radiation dose with and without specific hippocampal avoidance techniques in radiotherapy planning without compromising on the target structure doses. Secondly, this trial aims to study whether hippocampal sparing in radiotherapy leads to measurable reduction in neurocognitive decline.

Recruitment & Eligibility

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.
Non-Metastatic disease.
Curative Intent of treatment.

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.
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.

Primary Outcome Measures

Name	Time	Method
Dosimetric differences between hippocampal sparing & non-hippocampal sparing radiotherapy in patients of head & neck cancers	Radiotherapy Planning before Radiotherapy Treatment

Secondary Outcome Measures

Name	Time	Method
Neurocognitive function measured by ADDENBROOKEâ€™S COGNITIVE EXAMINATION â€“ ACE-III	3- & 6-months post radiotherapy follow-up
Acute toxicities as per RTOG criteria will be recorded	During Radiotherapy & 1 & 3 months post radiotherapy treatment

Locations (1): Mahamana Pandit Madan Mohan Malviya Cancer Center
🇮🇳
Varanasi, UTTAR PRADESH, India
Mahamana Pandit Madan Mohan Malviya Cancer Center
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Ashutosh Mukherji
Principal investigator
9489146747
drashutoshm@gmail.com