To assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Overall Survival, defined as time from randomization to death from any cause.
Secondary outcome
* Quality of life, assessed with the Functional Assessment of Cancer
Therapy: General (FACT-G).
* Toxicity, assessed by the National Cancer Institute Common Toxicity Criteria
(NCI- CTC) version 4 for each organ treated .
* Progression-free survival: time from randomization to disease progression at
any site or death.
* Lesional control rate.
* Number of cycles of further chemotherapy/systemic therapy.
Background summary
The oligometastatic disease state was first defined in 1995 and refers to an
stage of disease where cancer has spread beyond the site of origin, but is not
yet widely metastatic. In such a state of limited metastatic disease burden, it
is hypothesized that eradication of all sites of metastatic disease could
result in long-term survival, or even cure, in some patients. Ablation of
metastatic deposits can be achieved surgically, or through stereotactic
ablative radiotherapy (SABR), a new radiotherapy technology that delivers very
large, hypofractionated doses of radiotherapy to small tumor targets, with high
rates of local control.
Study objective
To assess the impact of a comprehensive oligometastatic SABR treatment program
on overall survival and quality of life in patients with up to 5 metastatic
cancer lesions, compared to patients who receive standard of care treatment
alone.
Study design
This study is designed as a randomized phase II screening study. Patients will
be randomized between current standard of care treatment (Arm 1) vs. standard
of care treatment + SABR (Arm 2) to sites of known disease. Patients will be
randomized in a 1:2 ratio to Arm 1 vs. Arm 2, respectively.
Intervention
Patients in the SABR-arm will receive stereotactic ablative radiotherapy to all
sites of metastatic cancer. Patients is the other group will receive standard
palliative care.
Study burden and risks
All patients will be asked to fill in a questionnaire regarding their quality
of life when visiting the hospital for the follow-up visits. This will take
about 5-10 minutes per visit.
The patients in the SABR-arm can experience toxicity regarding to the radiation
therapy.
de Boelelaan 1117
Amsterdam 1081HV
NL
de Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Age 18 or older.
Willing to provide informed consent.
Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
ECOG performance status 0-1.
Controlled primary tumor, defined as: at least 3 months since original tumor treated definitively, with no progression at primary site.
All sites of disease can be safely treated based on criteria below
• Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
• Life expectancy >6 months
• Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
• Prior chemotherapy allowed but no chemotherapy (cytotoxic or molecularly targeted agents) therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction. Hormonal therapy is allowed.
Patients with metastases that have been previously treated (e.g. prior resection, RFA or radiotherapy):
*If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
*If that previously treated metastasis is NOT controlled on imaging:
* If the previous treatment was surgery, the patient is eligible if
that site can be treated by SABR
* If the previous treatment was radiotherapy or RFA, the patient is ineligable;Patient presented at multidisciplinary tumor board or quality-assurance rounds.
Exclusion criteria
Serious medical comorbidities precluding radiotherapy
Bone metastasis in a femoral bone
Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
Prior radiotherapy to a site requiring treatment
Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
Malignant pleural effusion
Inability to treat all sites of active disease
Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on MRI.
Dominant brain metastasis requiring surgical decompression
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 | NCT01446744 |
| CCMO | NL40261.029.12 |