Status:
TERMINATED
INTENSE: A Phase I/II Study of INhomogeneous Targeted Dose Escalation in Non-Small CEll Lung Cancer
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 (...
Detailed Description
This is a prospective non-randomised Phase I/II cohort study; please see above for Radiation Therapy and Chemotherapy treatment details Each cohort will require a minimum of 6 and a maximum of 12 pat...
Eligibility Criteria
Inclusion
- 18 years of age
- ECOG (European Cooperative Oncology Group) performance status 0-2 (0-1 for concurrent chemotherapy)
- Weight loss \<10% within 3 months of diagnosis
- Histological diagnosis (biopsy or cytology) of NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell).
- Eligible NSCLC stages: IIA (provided N1); IIB (including T3N0 if unresectable or unsuitable for stereotactic ablative body radiation therapy (SABR)); IIIA and IIIB
- Inoperable (as per Multi-Disciplinary Team (MDT)) or patient refuses surgery
- Respiratory function:
- Forced Expiratory Volume (FEV1) ≥ 1L or ≥ 40% of predicted Diffusing Capacity of Lung for Carbon Monoxide (DLCO) ≥ 40%
- Radiological confirmation of disease via a Positron Emission Tomography (PET) scan prior to registration.
- Life expectancy, from causes other than lung cancer, of greater than 12 months (as per physician's opinion)
- Females of child bearing potential (see Appendix H) must not be pregnant and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control.
- Provision of written consent in line with ICH-GCP guidelines
Exclusion
- Previous thoracic radiation therapy
- Known co-existing or prior malignancy which is likely to interfere with treatment or assessment of outcomes
- Known distant metastases or metastatic pleural effusion
- Pancoast tumours (tumour of the pulmonary apex)
- Supraclavicular nodal involvement
- Spinal cord involvement
- Patients with syndromes or conditions associated with increased radiosensitivity or development of lung fibrosis
- Suitable for SABR
- Idiopathic pulmonary fibrosis/usual interstitial pneumonia
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating at the time of proposed randomisation
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
Key Trial Info
Start Date :
August 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02764086
Start Date
August 10 2016
End Date
June 5 2020
Last Update
April 6 2023
Active Locations (1)
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1
St Lukes Radiation Oncology Network (SLRON) at St Luke's Hospital and St James Hospital
Dublin, Ireland