Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Li… (NCT02200042) | Clinical Trial Compass
TerminatedPhase 3
Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer
United States1 participantsStarted 2014-09-29
Plain-language summary
This randomized phase III trial studies how well gemcitabine hydrochloride and cisplatin with or without radiation therapy work in treating patients with localized liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. It is not yet known whether giving gemcitabine and cisplatin is more effective with or without radiation therapy in this patient population. Patients register to this study after receiving gemcitabine and cisplatin.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis prior to study entry. Patients with an adenocarcinoma suggestive of a pancreaticobiliary primary with radiographic findings consistent with an intrahepatic cholangio-carcinoma are eligible.
✓. Patient must have 1 lesion with a maximum AXIAL diameter of 12cm at the time of study entry. Up to 3 satellite lesions are permitted. Satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (gross tumor volume \[GTV\]) are permitted. The satellite lesions are NOT included in the AXIAL diameter measurement. Regional Lymph Node involvement within the porta hepatis (as medial as superior mesenteric vein \[SMV\] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. FDG \[Fluorine 18 fluorodeoxyglucose\] avid);
✓. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
✓. Zubrod Performance Status 0-1 at the time of study entry;
✓. Age ≥ 18;
✓. Complete blood count (CBC) / differential obtained within 21 days prior to study entry, with adequate bone marrow function defined as follows:
✓. Patient must provide study specific informed consent prior to study entry;
What they're measuring
1
Overall Survival
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.
✓. Negative Beta-Human Chorionic Gonadotropin (bHCG) prior to study entry if patient is pre or peri-menopausal.
Exclusion criteria
✕. Multiple lesions that don't meet the criteria as satellite lesions as defined in protocol;
✕. Extrahepatic metastases or malignant nodes beyond the periportal region. Celiac, pancreaticoduodenal and para-aortic nodes\> 2 cm are ineligible. Note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \> 2.0 cm;
✕. Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed at the time of study entry;
✕. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields;
✕. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time;
✕. Direct tumor extension into the stomach, duodenum, small bowel or large bowel;
✕. Prior invasive malignancy, excluding the current diagnosis, (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (Note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible);
✕. Prior systemic chemotherapy for the study cancer other than gemcitabine/cisplatin; note that prior chemotherapy for a different cancer is allowable;