Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorRoswell Park Cancer Institute
About this trial
This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on survival in newly diagnosed metastatic patients with lung (Trial 1), colorectal (Trial 2), and prostate (Trial 3) cancers
Eligibility criteria
Qualifiers
Age 1 year or older.
Willing to provide informed consent.
ECOG ≤ 3.
Life expectancy > 6 months.
Disqualifiers
. Participants who have no option for standard systemic therapy or refuse systemic therapy.
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
Trial design
Treatments tested in this trial
- Stereotactic Ablative Radiotherapy
- Best Practice
Treatment groups
800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov