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INTENSE: A Phase I/II Study of INhomogeneous Targeted Dose Escalation in Non-Small CEll Lung Cancer
Sponsor: Cancer Trials Ireland
Summary
This is a prospective non-randomised Phase I/II study with patients recruited to escalated dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the conventional PTV (planning target volume), will be delivered to successive cohorts of participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity Projection (AVIP) dataset. Standard of care chemotherapy. There will be two treatment arms; one with patients who are planned to receive neo-adjuvant or no chemotherapy, and the other with patients who are planned to receive concurrent chemotherapy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2016-08-10
Completion Date
2020-06-05
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Radiation
Escalated dose of minimum 65Gy to the iGTV, with 60 Gy to PTV.
Locations (1)
St Lukes Radiation Oncology Network (SLRON) at St Luke's Hospital and St James Hospital
Dublin, Ireland