Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial
- Conditions
- lung cancernon-small cell lung carcinom10038666
- Registration Number
- NL-OMON43597
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
1. Patients > 18 years with any subtype of pathologically proven, non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.
2. Minimal diameter of the primary tumor 4 cm, to allow boosting of sub-volumes.
3. UICC Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).
4. Only stage IB-II patients who are not candidates for surgery are eligible
5 Measurable disease at registration.
6. ECOG-performance status < 2 (see appendix 6)
7. Lung function: FEV1 and DLCO at least 40 % of the age-adjusted normal value
8. Willing and able to give a written informed consent.
9. Patients with locoregional recurrent lung tumor following surgery or a second primary cancer (at least 3 years after treatment) are eligible, unless a pneumonectomy was performed.
10. SUVmax in the pre-treatment FDG-PET scan><= 5 for the primary tumor.
11. Adequate organ function, including the following:
a. Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) *1.5 x 109/L, platelets * 100 x 109/L, and hemoglobin * 9 g/dL.
b. Hepatic: bilirubin * 1.5 times the upper limit of normal (* ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) * 3.0 * ULN.
c. Renal: calculated creatinine clearance (CrCl) ><= 45 ml/min based on the original weight based Cockcroft and Gault formula
12 For women: Must be surgically sterile, postmenopausal, or compliant with a highly reliable contraceptive method (failure rate <1%) during and for 6 months after the treatment period, must not be breast-feeding.
13. For men: Must during chemotherapy take adequate contraceptive measures.
1. Prior radiotherapy to the thorax.
2. Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion.
3. Tumor growth in large blood vessels on spiral CT scan or encasement >50 %
4. Multiple nodules in the same or ipsilateral lobe(s).
5. Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan.
6. Patients with a diagnosis of other cancer within the last 3-years (except in situ carcinoma*s and / or non-melanoma skin cancer).
7. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Freedom from local failure in patients alive at 1 year</p><br>
- Secondary Outcome Measures
Name Time Method <p>Toxicity<br /><br>Overall survival<br /><br>Quality of life<br /><br>Distant metastases<br /><br>Local and regional failures outside PTV<br /><br>Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy<br /><br>based on average PET CT , 18F HX4 and DCE-CT scan<br /><br>Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy<br /><br>based on average PET CT and 18F HX4.<br /><br>Correlation between distant metastases and 18F HX4 uptake in the primary tumor.</p><br>