Combined stereotactic radiotherapy and conventional fractionation in stage II and II lungcancer.

• Conditions: SCLC stage III or inoperable stage II; MedDRA version: 14.1Level: PTClassification code 10062041Term: Lung infiltration malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10025036Term: Lung adenocarcinoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10023779Term: Large cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10062042Term: Lung neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10025082Term: Lung disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10025069Term: Lung carcinoma cell type unspecified stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10001250Term: Adenosquamous cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl

• Registration Number: EUCTR2012-002392-33-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-04
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

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

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

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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To define the recommended phase II mean-lung dose (MLD) to treat peripheral stage II or III non small cell lung cancer (NSCLC) using stereotactic ablative radiotherapy (SABR) for the primary tumor and conventional fractionated radiotherapy (CFRT) for the mediastinal lymph nodes while given concurrent chemotherapy;Secondary Objective: •To describe toxic effects of the Hybrid treatment<br>•To assess the overall treatment time <br>•Evaluation of local control<br>•Evaluation of regional control<br>•Evaluation of overall survival<br>•Evaluation of local effect on normal tissue changes <br>;Primary end point(s): The mean-lung dose that is associated with a 15 % probability of dose limiting toxicity, defined according to the CTCAE v4.03; radiation pneumonitis = grade 3 and radiation induced dyspnea = grade 3. ;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1) 1 year <br>2-6) 2 years;Secondary end point(s): 1)To describe toxic effects of the Hybrid treatment<br>2)To assess the overall treatment time <br>3)Evaluation of local control<br>4)Evaluation of regional control<br>5)Evaluation of overall survival<br>6)Evaluation of local effect on normal tissue changes <br>