TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, … (NCT03297710) | Clinical Trial Compass
CompletedPhase 1
TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery
United States7 participantsStarted 2017-12-11
Plain-language summary
This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.
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:
* Histological or cytological confirmation of locally recurrent or metastatic rectal adenocarcinoma
* Note: Patients with locally recurrent/persistent disease within the pelvis after primary therapy (chemotherapy, surgery, and/or radiotherapy) are eligible
* Note: Patients who have had prior pelvic radiotherapy with a total dose of =\< 54 Gy are eligible
* Note: Patients with or without metastatic disease (excluding untreated central nervous system \[CNS\] metastasis), with primary pelvic disease or pelvic recurrence are eligible
* Note: Patients with pelvic disease that is potentially resectable or unresectable are eligible
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Expected life expectancy \>= 12 weeks
* Obtained =\< 14 days prior to registration: Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Obtained =\< 14 days prior to registration: Platelet count \>= 100,000/mm\^3
* Obtained =\< 14 days prior to registration: Hemoglobin \>= 9.0 g/dL
* Obtained =\< 14 days prior to registration: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert's syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =\< 1.0 mg/dL)
* Obtained =\< 14 days prior to registration: Aspartate transaminase (AST) =\< 2 x ULN (=\< 5 x ULN for patients with liver involvement)
* Obtained =\< 14 days prior to registration: Alanine aminotransferase (ALT) =\…
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.