BridgeMD
New treatment option for Stage IV Esophageal Adenocarcinoma
Official title Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
ClinicalTrials.gov ID: NCT04221893
What this study is testing
- What it's testing
- This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal...
- Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
- Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as...
- Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating...
- Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea
You likely can't join if
- Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
- Administration of radiation therapy within 4 weeks prior to study enrollment.
- Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as...
- Radiation therapy is contraindicated as adjudicated by the radiation oncologist.
See the full eligibility criteria
- Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary...
- Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
- Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which...
- Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:
- Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea
- At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise
- Evaluation by a radiation oncologist within 28 days of study registration.
- Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
- Age \>= 18 years.
- Life expectancy exceeding 6 months.
- Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \>= 50.
- Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the...
- Ability to understand a written informed consent document, and the willingness to sign it.
- Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
- Administration of radiation therapy within 4 weeks prior to study enrollment.
- Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.
- Radiation therapy is contraindicated as adjudicated by the radiation oncologist.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Walnut Creek, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Walnut Creek, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.