Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
This trial is active, not recruiting.
|Treatments||3-dimensional conformal radiation therapy, intensity-modulated radiation therapy, stereotactic body radiation therapy|
|Phase||phase 1/phase 2|
|Sponsor||Swiss Group for Clinical Cancer Research|
|Start date||November 2008|
|End date||January 2014|
|Trial size||73 participants|
|Trial identifier||NCT00777894, EU-20884, SAKK 77/07, SWS-SAKK-77/07, SWS-SASL-26|
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an effective treatment for liver cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam radiation therapy in treating patients with liver cancer that cannot be removed by surgery.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Maastricht, Netherlands||Maastro Lab at University of Maastricht||no longer recruiting|
|Aarau, Switzerland||Kantonsspital Aarau||no longer recruiting|
|Basel, Switzerland||Universitaetsspital-Basel||no longer recruiting|
|Bellinzona, Switzerland||Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
|St. Gallen, Switzerland||Kantonsspital - St. Gallen||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Dose-limiting toxicity (Phase I)
time frame: during RT or within 30 days after the last RT dose, is a DLT.
Best objective response of target liver lesions (TLLs)
time frame: according to RECIST criteria for up to 1 year after completion of study therapy (Phase II)
Best objective response of TLLs according to RECIST criteria (Phase I)
time frame: according to RECIST criteria (Phase I)
Adverse events according to NCI CTCAE v.3.0
time frame: during therapy and within 3 months after completion of study therapy (Phases I and II)
Volumetric response of TLLs
time frame: at 5 months after completion of study therapy (Phase II)
Time to progression of TLLs (Phase II)
time frame: calculated from registration until documented tumor progression of target liver lesions.
Duration of response of TLLs (Phase II)
time frame: the time from achieving an objective response (CR + PR) to a progression of target liver lesions according to RECIST or death.
Stable disease of TLLs (Phase II)
time frame: will be determined according to RECIST
Time to liver event (Phase II)
time frame: from registration until progressive liver disease.
Progression-free survival (Phase II)
time frame: calculated from registration until documented tumor progression or death, whichever occurs first.
Overall survival (Phase II)
time frame: calculated from registration until death
Compensatory liver tissue hypertrophy at baseline and at 5 months after completion of study therapy (Phase II)
time frame: Increase in residual liver volume (= total liver - GTV) (ml) between registration and 5 months after RT will be calculated
time frame: at last study visit and at 1, 2, 3, and 5 months after completion of study therapy (Phase II)
Serum alpha-fetoprotein level (Phase II)
time frame: will be measured until progression, if AFP is ≥ 1.5 x ULN at baseline.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma - Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1, N0-1, M0 (stage I) disease - M1 disease allowed in phase I if at least 90% of the tumor load (volume) is in the liver - Measurable disease (at least one liver lesion that can be measured in at least one dimension as ≥ 10 mm in multislice CT scan/MRI) - Volumetry of liver tumor and residual liver tissue: residual liver volume (= total liver volume - gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume - No operable disease (with curative intent or planned liver transplantation) - No presence of clinical ascites PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9) - Hemoglobin ≥ 100 g/L - ANC ≥ 1,200/mm³ - Platelet count ≥ 50,000/mm³ - ALT and AST ≤ 7 times upper limit of normal (ULN) - AP ≤ 10 times ULN - Bilirubin ≤ 50 μmol/L - INR ≤ 2 - Creatinine clearance ≥ 50 mL/min - Functional left kidney (scintigraphy mandatory for phase I, phase II only if indicated) - Lipase ≤ 2 times ULN (phase I only) - Able to tolerate proton-pump inhibitors or H2 antagonists during radiation therapy - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 months after completion of study therapy - No prior malignancy allowed, except for the following: - Adequately treated cervical carcinoma in situ - Adequately treated localized nonmelanoma skin cancer - Any other malignancy from which patient has been disease-free for 5 years - No presence of medically uncontrolled encephalopathy - No myocardial infarction within the past 6 months - No esophageal varices ≥ grade 3, with red signs, or bleeding within the past 3 months - No symptoms of colitis, enteritis, esophagitis, fistula, gastritis, ileus, necrosis, perforation, stricture, or ulcer - No severe anorexia, constipation, dehydration, diarrhea, or vomiting - No serious underlying medical condition that, in the opinion in the investigator, would preclude study participation (e.g., active autoimmune disease or uncontrolled diabetes) - Portal vein thrombosis allowed - No psychiatric disorder precluding understanding of information on study related topics or giving informed consent - No nutritional intake < 1500 calories per day (corrected) - No weight loss ≥ 15 % within the past 3 months PRIOR CONCURRENT THERAPY: - At least 8 weeks since prior transarterial chemoembolization (TACE), radiofrequency ablation, or radiotherapy (RT) unless progressive disease was documented after this therapy - At least 21 days since prior and no other concurrent treatment with experimental drugs - At least 21 days since prior and no other concurrent treatment on another clinical trial - At least 21 days since prior and no other concurrent anticancer therapy - No prior RT to the abdomen or caudal chest - Prior RT to pelvis allowed - Prior RT to chest must be above D5 vertebra - Portal vein embolization ligation or pre-RT TACE allowed - No concurrent treatment with steroids or non-steroidal anti-inflammatory drugs during RT (proton-pump inhibitor allowed)
|Official title||External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.|
|Description||OBJECTIVES: - To assess the feasibility and safety of radiotherapy (RT) in patients with hepatocellular carcinoma. (Phase I) - To assess the safety and efficacy of RT in these patients. (Phase II) - To generate reproducible peptide patterns of the serum proteome or specific serum sub proteomes in these patients. - To assess changes in the proteome or sub proteome patterns after RT in these patients. - To detect peptides that discriminate between before and after RT in these patients. - To identify these discriminating peptides in these patients. OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study. Patients undergo radiotherapy (RT) once daily, five days a week, for 6 weeks. Intensity-modulated, 3-dimensional conformal, or fractionated stereotactic RT may be used. After completion of study therapy, patients in the phase I portion are followed for 1 year and patients in the phase II portion are followed for 3 years.|
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