Phase I Hybrid study: combined stereotactic radiotherapy and conventional fractionation in stage II and III non small cell lung cancer with peripheral tumors smaller than 5 cm

Completed

Conditions: Lung cancer
Non small cell lung cancer
10038666

Registration Number: NL-OMON39053

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).

• WHO-performance status <= 2 (Appendix B)

• Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine (section 6.3)

• FEV1 and DLCO > 40 % of the age-adjusted normal value

o 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.

o Hepatic: bilirubin <= 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) <= 3.0 × ULN.

o Renal: calculated creatinine clearance (CrCl) >= 45 ml/min based on the original weight based Cockcroft and Gault formula.

• Before patient registration, written informed consent must be given according to GCP and national regulations

Exclusion Criteria

• Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.

• Patients that receive sequential chemoradiotherapy or radiotherapy only.

• Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)

• Patients with Pancoast tumors

• Pregnant women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The mean lung dose that is associated with a 15% probability of a dose limiting<br /><br>toxicity, defined according to the CTCAE v4.03: radiation pneumonitis grade >= 3<br /><br>and radiation induced dyspnea grade >= 3.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To describe toxic effects of the Hybrid treatment<br /><br>. To assess the overall treatment time<br /><br>. Evaluation of local control<br /><br>. Evaluation of regional control<br /><br>. Evaluation of overall survival<br /><br>. Evaluation of local effect on normal tissue changes</p><br>