The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Freedom from local failure in patients alive at 1 year
Secondary outcome
Toxicity
Overall survival
Quality of life
Distant metastases
Local and regional failures outside PTV
Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy
based on average PET CT , 18F HX4 and DCE-CT scan
Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy
based on average PET CT and 18F HX4.
Correlation between distant metastases and 18F HX4 uptake in the primary tumor.
Background summary
Local tumor failure remains high in patients with stage IB, II and III
non-small cell lung cancer (NSCLC), with local progression free survival (LPFS)
rates of about 30 %, even with concurrent chemo-radiation
Radiation dose-escalation can further increase local tumor control rates,
especially when radiotherapy is delivered in a short overall treatment time.
Because of dose-limiting toxicity, individualized radiation dose-prescription
on the basis of normal tissue dose constraints has been investigated, in
conjunction with target volume definition on the basis of 18F-deoxyglucose
(FDG)-Positron Emission Tomography (PET)-CT scans. The pre-treatment FDG uptake
in the tumor, quantified by the SUV-value and the pre-radiation volume of the
tumor is prognostic for the local tumor control.
The question however remains whether delivering a higher radiation dose to the
most avid FDG-uptake areas within the tumor may improve local tumor control.
A randomized phase II study will be conducted in patients with inoperable stage
IB, II or III non-small cell lung cancer (NSCLC). The patients will be
randomized to receive the standard 66 Gy given in 24 fractions with an
integrated boost to the primary tumor as a whole (Arm A) or with an integrated
boost to the 50% SUVmax of the primary tumor (of the pre-treatment PET FDG
scan) (Arm B)
Study objective
The primary objective of this study is to determine the freedom from local
failure in patients alive at 1 year
Study design
This study is a randomized multi-institutional phase II trial
Intervention
Radiotherapy with integrated boost on primary tumor on the basis of a
pre-treatment FDG-PET-CT scan
Study burden and risks
The treatment in this study will give rise to side effects comparable to
standard radiotherapy of non-small cell lung cancer (dysphagia, radiation
pneumonia). The side effects are possibly more severe but probably reversibel.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01024829 |
| CCMO | NL28000.031.09 |