Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC (NCT02254681) | Clinical Trial Compass
TerminatedPhase 2
Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC
Stopped: lack of funding
United States6 participantsStarted 2014-09
Plain-language summary
The overall goal of this study is to determine the safety and efficacy of combination treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy for locally advanced mass forming intra-hepatic cholangiocarcinoma.
Who can participate
Age range18 Years – 99 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:
* Histologic diagnosis of mass-forming IHC. OR
* Histologic diagnosis of adenocarcinoma of the liver in setting of negative colonoscopy, upper endoscopy, mammography (females), or cross-sectional imaging for primary disease.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with spiral CT scan, MRI. See Section 8 for the evaluation of measurable disease.
* Locally advanced disease (portal lymph node disease, multifocal intrahepatic lesions, or major vascular invasion) AND no evidence of omental, peritoneal, or pelvic metastases.
* Other sites of metastatic disease (e.g. lung, distant lymph nodes, bone) are allowed.
* No prior chemotherapy, radiotherapy, or surgical therapy.
* ECOG performance status ≤ 1 (Karnofsky ≥70%). See Appendix A.
* Life expectancy of greater than six months.
* Patients must have normal organ and marrow function as defined below:
* leukocytes≥3,000/mcL
* absolute neutrophil count≥1,500/mcL
* platelets ≥100,000/mcL
* hemoglobin≥9.0 g/dL
* total bilirubin≤2.0 mg/dL
* AST(SGOT)/ALT(SGPT)≤3 × institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* int'l normalized ratio\<1.8
* systolic blood pressure≤160 mmHg
* diastolic blood pressure ≥90 mmHg
* For women of child-bearing potential, negative serum pregnan…
What they're measuring
1
Number of Participants With Radiographic Disease Response After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.