This study is important in that not only will we learn information about the true oncologic differences between these therapies, we will also determine the relative impact of these therapies on pulmonary function and quality of life.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To ascertain whether patients treated by SBRT have a 3-year overall survival
(OS) rate that is no more than 10% less than patients treated with SR.
Secondary outcome
To compare the following items between SR and SBRT:
* Loco-regional recurrence-free survival.
* Disease-free survival.
* Grade 3 or higher specific adverse event profiles
* Pulmonary function.
* Adverse events and PFTs in each arm for patients with low or high Charlson
comorbidity index scores, including a test interaction between Charlson
comorbidity index scores (low vs. high) and treatment arm.
Correlative science objectives:
* To compare the quality-adjusted survival between the treatments SBRT and SR
in terms of time to death (primary) and time until recurrence (secondary).
* To examine whether pre-operative and post-operative clinically significant
deficits in previously-identified prognostic PRO domains (overall QOL, fatigue,
anxiety, dyspnea) are associated with shorter patient survival in this patient
population and to compare the relative effectiveness of each treatment (SBRT
and SR).
* To contribute to an ACOSOG bank of normative data in order to improve
short/long term outcomes of cancer patients by identifying patients
experiencing clinically significant deficits in patient-reported outcomes and
the relationship to genetic variables.
* To explore whether blood based biomarkers, including osteopontins, will be
able to predict which patients will be at high risk for recurrence by treatment
with either SBRT or SR.
* To explore whether blood based biomarkers, including TGF-*1, will be able to
predict which patients will be at high risk for pulmonary complications by
treatment with either SBRT or SR.
Background summary
Stage I lungcancer is potentially curable. Patients can be divided into 3
categories based on their pre-existing medical history: 1) standard risk
operable 2) High-risk operable patients and 3) medically inoperable. Patients
in category 1 and 3 are treated with respectively lobectomy/pneumonectomy or
stereotactic body radiation therapy (SBRT). For patients in category 2 better
therapies are needed.
There have not been any prospective, randomized trials to compare the efficacy
or the toxicity profile of SR to SBRT in high risk patients. Currently, it is
difficult to make comparisons between the therapies because in the available
literature the definitions of local recurrence, local control, and regional
recurrence are not uniform and toxicity is scored by different means. This has
led to different perceptions and interpretations of the published literature
relating to these modalities.
Study objective
This study is important in that not only will we learn information about the
true oncologic differences between these therapies, we will also determine the
relative impact of these therapies on pulmonary function and quality of life.
Study design
This is a prospective, randomized Phase III trial comparing SR and SBRT for
high-risk patients with operable lung cancer.
Intervention
Patients in both groups will get an intervention. Half of patients will be
treated with a sublobar resection. The other half will be treated with
stereotactic body radiation therapy.
Study burden and risks
Patients in both arms (SR and SBRT) can experience adverse events correlated to
the treatment. Because both treatments are also used for patients outside this
study, we expect no additional chance on toxicity for the participating
patients.
All participating patients may have to visit the hospital more often than
non-participating patients. On eight visits they will be asked to complete a
questionnaire. This wil cost an extra 5 to 15 minutes. The visits itself and
the imaging during follow-up will not differ from the follow-up in
non-participating patients.
de Boelelaan 1117
Amsterdam 1081HV
NL
de Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Age: 18 years or older
ECOG performance status of 0, 1 or 2
Patients at high risk for surgery (see protocol for criteria)
Lung nodule suspicious for NSCLC (biopsy confirmation is strongly recommended)
Clinical stage Ia or Ib, no evidence of metastases
All clinically suspicious mediastinal lymph nodes confirmed negative
Tumor verified by thoracic surgeon to be in location that permits sublobar resection
Exclusion criteria
Evidence of metastases
Tumor >2 cm of bronchial tree
Prior intrathoracal radiotherapy
Previous chemotherapy or surgery for lungcancer treated on this protocol
Pregnant or lactating
Invasive cancer < 3 years prior to registration (exception, non melanoma skin cancer or in-situ cancer)
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 | NCT01336894 |
| CCMO | NL40733.029.12 |