Individualized Dose Escalation for non-small cell Lung cancer (NSCLC) using volumetric modulated arc therapy (VMAT)

Phase 2

Completed

Conditions: Lung cancer
10038666

Registration Number: NL-OMON36216

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Histologically or cytologically confirmed stage IIIA/B NSCLC (excluding pleural effusion or mixed pathology)
2. Irresectable disease (as assessed by multidisciplinary team) or patient refusing surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating center
4. Proposed treatment consists of radiotherapy alone, induction chemotherapy followed by radiotherapy, or concurrent chemoradiation
5. WHO performance status 0 or 1
6. Adequate respiratory function: FEV1 * 1.5 L and DLCO > 40%, predicted on baseline pulmonary function tests
7. Age * 18 years, no upper age limit
8. Estimated life expectancy of more than 6 months
9. Patient is available for follow-up
10. Written informed consent obtained

Exclusion Criteria

1. Clinically diagnosed NSCLC
2. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
3. Prior thoracic radiotherapy
4. Prior lobectomy / pneumonectomy
5. Prior chemotherapy using gemcitabine or bleomycine
6. Superior sulcus tumors if the brachial plexus is within the high-dose volume
7. Medically unstable (e.g., ischaemic heart disease, esophageal disorders)
8. Pregnancy
9. Connective tissue disorders
10. Inability to comply with protocol or trial procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment toxicity in terms of acute or late grade 2-4 esophageal and pulmonary<br /><br>adverse events, or other grade 2-4 adverse events (RTOG Acute Radiation<br /><br>Morbidity Scoring Criteria and RTOG/ESTRO Late Radiation Morbidity Scoring<br /><br>Schema)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Local-regional failure<br /><br>Progression-free survival<br /><br>Overall survival<br /><br>Death during or within 30 days of discontinuation of radiation treatment<br /><br>Quality of life (EORTC questionnaire QLQ-C13 and QCQ-LC13, H.A.D.S.<br /><br>questionnaire)<br /><br><br /><br>Predictive value of 18F-fluoroglucose (18FDG-)PET of the primary tumor and<br /><br>metastatic mediastinal lymph nodes performed at three time-points: before,<br /><br>during (2nd week) and (3 months) after treatment; findings on 18FDG-PET-CT<br /><br>scans performed during treatment will not alter this.<br /><br><br /><br>For patients undergoing surgery after (chemo)radiation (in accordance with the<br /><br>local protocol):<br /><br>Rate of pathological complete responses of the primary tumor and rate of<br /><br>non-viable tumor cells in<br /><br>treated mediastinal lymph nodes<br /><br>Correlation of immunohistochemical findings with alterations of the 18FDG-PET<br /><br>signal</p><br>