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TERMINATED
NCT02764086
PHASE1/PHASE2

INTENSE: A Phase I/II Study of INhomogeneous Targeted Dose Escalation in Non-Small CEll Lung Cancer

Sponsor: Cancer Trials Ireland

View on ClinicalTrials.gov

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

Interventions

RADIATION

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