Feasibility trial on combination of platinum doublets and hypofractionated radiotherapy for locally advanced stage non-small cell lung carcinoma
- Conditions
- lung cancernon-small cell lung cancer1002765510029107
- Registration Number
- NL-OMON56676
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
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, with a clinical indication for concurrent chemo-irradiation.
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
a. Adequate 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.
b. Hepatic:
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 hyperbilirubinaemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.
c. Renal: 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.
1. WHO*performance status * 2
2. FEV1 and DLCO < 35 % of the age- and sex*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. Participation in another clinical study with an investigational product during the last 4 weeks.
6. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
7. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of chemotherapy.
8. 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
9. 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
10. 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
11. 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the safety of concurrent high dose chemotherapy with hypofractionated<br /><br>radiotherapy as defined by the rate of grade 5 treatment-related adverse events<br /><br>that occur during treatment and 3-month follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The one-year disease control rate.<br /><br>- Progression free survival<br /><br>- Overall survival.</p><br>