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Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial

ConditionsOligometastasisLung CancerColo-rectal CancerProstate Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Ablative Radiotherapy

    Procedure/Surgery

    Radiation therapy begins after 3 months of Standard of care

  • Best Practice

    Other intervention

    Receive standard of care therapy

Treatment groups

800 Participants
are divided into 3 treatment groups
Group A: Standard Therapy followed by SABR - Trial 1-3 Arm 1Experimental treatment 2 interventions
Group B: SABR plus Standard therapy - Trial 1-3 Arm 2Experimental treatment 2 interventions
Group C: Trial 4 - Immediate SABR plus standard of careExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival - Trial 1 and 2

Calculated from the time of randomization until death

Time frame
UP to 5 years
2

Androgen DeprivationTherapy (ADT)-free survival - Trial 3

The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up.

Time frame
Up to 5 years

Secondary outcomes

1

Change in Quality of Life

Quality of life will be assessed using The EORTC Core Quality of Life questionnaire (EORTC-QLC30). This questionnaire measures cancer patients' physical, psychological and social functions. This 30 item questionnaire ranges from 1 (not at all ) to 4 (Very much) except for the global health status/quality-of-life scale, which has response options ranging from (1) "very poor" to (7) "excellent"

Time frame
Up to 5 years after radiation treatment
2

Physician determined Radiation related toxicity

To document toxicity in patients using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5 for each organ treated

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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