Study on Stereotactic Ablative Radiotherapy (SABR) for Treating Patients with Metastatic Cancer, ID-COMET Trial

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06563388

This clinical trial is exploring the effects of immediate versus delayed comprehensive radiation treatment on survival in patients newly diagnosed with metastatic lung, colorectal, and prostate cancers.

Patient Parameters

Program Overview

The purpose of this study is to compare the outcomes of starting comprehensive radiation treatment right away versus waiting three months in patients who have just been diagnosed with metastatic cancer. The study focuses on three types of cancer: lung, colorectal, and prostate. It aims to see which approach is more effective in improving survival rates.

Eligibility Criteria

Inclusion Criteria

  • Age 1 year or older.
  • Willing to provide informed consent.
  • ECOG performance status of 3 or less, meaning you can still perform some daily activities.
  • Life expectancy of more than 6 months.
  • For Trials 1-3: Diagnosed with lung, prostate, or colorectal cancer that has spread to other parts of the body, confirmed by imaging. A biopsy of the spread is preferred but not required.
  • For Trial 4: Any type of cancer with spread. Patients with blood cancers are eligible if they have confirmed disease that is resistant to treatment and are eligible for radiation therapy.
  • Newly diagnosed metastatic patients for Trials 1-3. Previously diagnosed metastatic patients for Trial 4.
  • Recent imaging tests completed within 12 weeks before joining the study.
  • For those receiving chest radiation, a doctor must confirm there are no signs of lung disease on previous CT scans. If there are signs, a lung specialist must rule out lung disease before joining.
  • Participants who can have children must agree to use effective birth control methods before joining the study.
  • If a woman becomes pregnant or thinks she might be while participating, she should inform her doctor immediately.
  • Must understand the study is experimental and sign a consent form before any study procedures.

Exclusion Criteria

  • No option for standard treatment or refusal of standard treatment.
  • Recent chemotherapy or radiation within 3 weeks (or 6 weeks for certain drugs) before joining the study, or not recovered from side effects of previous treatments.
  • Serious health conditions that prevent radiation therapy, such as lung disease for chest radiation, Crohn's disease for gastrointestinal radiation, or connective tissue disorders like lupus.
  • Moderate to severe liver problems for those with liver cancer spread.
  • Overlapping previous radiation treatment areas that exceed safe limits.
  • Malignant fluid buildup in the chest.
  • Inability to treat all cancer sites.
  • Cancer that has spread to the digestive tract or skin.
  • Known brain cancer spread due to poor prognosis and potential for worsening symptoms.
  • Uncontrolled health issues like infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that affect study participation.
  • Pregnant or breastfeeding women.

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