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 range18 Years
SexALL
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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) =\…