Trial with combination of platinum based chemotherapy and hypofractionated radiotherapy for non-small cell lung cancer

Phase 1

• Conditions: ocally advanced non-small cell lung carcinoma stage III or inoperable stage II; MedDRA version: 19.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025053Term: Lung cancer non-small cell stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025051Term: Lung cancer non-small cell stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025052Term: Lung cancer non-small cell stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10001252Term: Adenosquamous cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10001253Term: Adenosquamous cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025060Term: Lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10025061Term: Lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2016-003790-18-NL
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-30
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of signed, written and dated informed consent prior to any study specific procedures
2.Male or female aged 18 years or older
3.Cytological or histological proven NSCLC stage III or inoperable stage II (cT1-3-3N0-1), according to the 8th edition of the AJCC staging.
4.Patients with locoregional recurrent lung tumor following surgery or a second primary cancer are eligible, unless a pneumonectomy was performed.
5.Minimum required laboratory data
oAdequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets = 100 x 109/L, and hemoglobin = 5.5 mmol/L.
oHepatic:
i.Serum bilirubin = 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) = 3.0 × ULN.
ii.This does not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubin aemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.
oRenal: GFR = 60 ml/min; if below this threshold a creatinine clearance (CrCL) can be calculated based on the original weight based Cockcroft and Gault formula and should be = 45 ml/min.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.WHO performance status = 2
2.FEV-1 and DLCO < 35 % of the age- and gender adjusted normal value
3.Patients with grade 3 dyspnea or worse at baseline (according to CTCAE version 4.03)
4.Prior radiotherapy to the thorax.
5.Mean lung dose > 20.0 Gy and/or exceeding other organs-at-risk constraints.
6.Participation in another clinical study with an investigational product during the last 4 weeks.
7.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
8.Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of chemotherapy.
9.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
10.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
11.Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
12.Any condition that, in the opinion of the investigator, would interfere with evaluation of the chemoradiotherapy or interpretation of patient safety or study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified