To compare the outcomes of stereotactic radiotherapy (experimental arm) with that following primary surgery (standard arm) in a prospective phase III trial.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Lower respiratory tract disorders (excl obstruction and infection)
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare local and regional control, quality of life and treatment costs at
2- and 5-years, in patients with stage IA NSCLC who are randomized to either
surgery or radiosurgery.
Secondary outcome
Overall survival, pulmonary function tests, quality adjusted life years
(QALYs), total costs (both direct and indirect).
Background summary
Stage I non-small cell lung cancer only makes up 20% of the nearly 9000
patients diagnosed to have lung cancer in the Netherlands. Despite a complete
surgical resection, tumor recurrences are seen in nearly 35% of patients, and
the 5-year survival is less than 70%. More effective, and less toxic,
treatments are needed. Stereotactic radiotherapy is a well-tolerated outpatient
procedure which can achieve local control in more than 90% of patients with
medically-inoperable stage IA NSCLC.
Study objective
To compare the outcomes of stereotactic radiotherapy (experimental arm) with
that following primary surgery (standard arm) in a prospective phase III
trial.
Study design
A prospective phase III trial.
Intervention
Primary stereotactic radiatherapy will be the experimental arm, and patients
will receive a dose of 60Gy in either 3 or 5 fractions.
Study burden and risks
The commonest complications described after stereotactic radiotherapy
(experimental arm) are chest pain and radiation-induced lung inflammation.
However, this has been described in less than 6% of treated patients and
studies of quality of life after stereotactic radiotherapy show less impairment
than after surgery (standard arm). Patients undergoing stereotactic
radiotherapy are at greater risk of tumor recurrences in hilar and mediastinal
nodes, but these are amenable to salvage treatment options with surgery and/or
chemo-radiotherapy.
De Boelelaan 1117, Postbus 7057
1007 MB Amsterdam
Nederland
De Boelelaan 1117, Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Age * 18 years;Patients with a diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines. When no pathological diagnosis is available, a patient with a new or growing pulmonary lesion with radiological features consistent with malignancy AND a lesion showing uptake on a FDG-PET scan will be eligible. ;No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment .;Medial extension of tumours should be least 2 cm away from main and lobar bronchi, and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and main pulmonary artery. Lesions of at least 2 cm from the mediastinal pleura will be eligible if the responsible radiation oncologist judges that the specified normal tissue tolerance doses specified in the protocol will not be exceeded.;Patients should be fit to undergo both surgery and SRT. ;Patients who are judged by a multi-disciplinary team to have 2 primary lung tumors (on the basis of clinical, radiological, FDG-PET and/or cyto-pathology findings) are eligible for randomization provided that both surgery and SRT can be performed in accordance with protocol requirements.;Patient should be fit to undergo a complete surgical resection of the lesion in accordance with Dutch CBO guidelines [2004] ;Performance score of ECOG * 2 before any treatment.;Able to comply with post-treatment follow-up
Exclusion criteria
Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC. ;History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, with the exception of non-melanoma skin cancers or in-situ cervical cancers.;Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).;Concomitant treatment with any other experimental drug under investigation.
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 | NCT00687986 |
| CCMO | NL23511.029.08 |