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Clinical Trials in India / NCT04655469
Active, not recruiting Observational

Personal Health Train for Radiation Oncology in India and The Netherlands

NCT04655469 · tracked via the Priya Life Science India tracker
Sponsor
Maastricht Radiation Oncology
Phase
Observational
Started
2020-04-10
Last updated
2025-08-22

Condition(s) studied

Head and Neck Carcinoma

Study summary

The primary and general objective of this protocol as the current standard of care is to improve the quality of radiotherapy for HNC patients. This will ultimately be achieved by optimizing locoregional tumour control and overall survival and by reducing radiation-induced side effects.

It will also allow the assessment of the effects of newly introduced radiation technology (e.g. proton therapy) for this particular group of patients.

The clinical introduction of this standard follow-up program (SFP) will allow for a systematic and broad scale quality improvement cycle for HNC patients treated with radiotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) * Head and Neck primary tumor site: oral cavity, oropharynx, larynx or hypopharynx * Treated between 01-2008 and 12-2017 * Clinical stage III and IV (a, b) according to TNM 7th edition * No distant metastases (M0) * Treated with curative intent: primary definitive radiation therapy with or without systemic treatment * Availability of baseline imaging: * Planning CT scan of the HN region in treatment position, with RT-structures available, performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast * (if available) FDG-PET in treatment position Exclusion Criteria: * Any previous HNC * Patients with previous malignancies in the last 5 years before treatment for HNC, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin * Any previous malignancy that was treated with surgery and/or radiation of the head and neck region * Histological type other than HNSCC * Cancers originating in the oral cavity, nasopharynx, salivary glands or sinonasal area * Postoperative radiation treatment setting

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Healthcare Global Bengaluru Karnataka
Tata Memorial Hospital Mumbai Maharashtra
Maastro Maastricht Limburg
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04655469 on ClinicalTrials.gov ↗ ← All trials in India