Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II) (NCT02152254) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)
United States1,362 participantsStarted 2014-05-13
Plain-language summary
This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with metastatic cancer
* Patients may have received unlimited lines of prior therapy
* Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
* The patient has measurable disease
* The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* The patient has biopsy-accessible tumor; for patients who had no prior anticancer therapy and had surgical resection within a year and tumor tissue is immediately available, that tumor will be analyzed and no biopsy will be needed
* Absolute neutrophil count \>= 1,000/ul
* Platelets \>= 100,000/ul (unless these abnormalities are due to bone marrow involvement)
* Total bilirubin level \<= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease
* Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) =\< 2.5 X ULN (unless the patient has liver metastases)
* Serum creatinine clearance \>= 50 ml/min by the Cockcroft-Gault formula
* If the patient has brain metastasis, they must have been stable (treated and/or asymptomatic) and the patient must have been off steroids for at least 2 weeks
* The patient has provided signed informed consent
* Patients with a previous malignancy (other than the patients' known cancer) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Timeframe: Continuous Monitoring, expected range from 2 months to 3 years