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Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers

Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036821
Enrollment
34
Registered
2021-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

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

Interventions

Intervention1: Mid treatment replanning: Patients on IMRT/Chemo-IMRT are rescanned after 20th fraction and replanned and new plan is executed at 22nd fraction Control Intervention1: Not applicable:

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven Squamous Cell Carcinoma of head and neck region 2. Age 3. Primary tumour sites in oral cavity, oropharynx, hypopharynx and larynx. 4.Stage III-IVB by AJCC Cancer Staging Manual Eight Edition, 2018 5.Eastern Cooperative Oncology Group (ECOG) performance status 6.All patients fit for chemo-radiation/Radiation Therapy

Exclusion criteria

Exclusion criteria: 1. Patients with resection of the primary tumour or recurrent disease 2. Patients with distant metastasis 3. Patients who have received prior NACT or surgery 4. Patients who have received prior radiation therapy.

Design outcomes

Primary

MeasureTime frame
To assess the quality of life in Locally advanced Head and Neck cancer patients undergoing IMRT/Chemo-IMRT with mid treatment adaptive replanningTimepoint: 6 months

Secondary

MeasureTime frame
1. To asses acute toxicity during 6 weeks in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning 2. To assess the incidence of xerostomia at 6 months in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Sweety Gupta

AIIMS Rishikesh

drsg2411@yahoo.co.in9891981332

Outcome results

None listed

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