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Status:

COMPLETED

Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Liver Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

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 dos...

Detailed 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) * ...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    November 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2015

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00777894

    Start Date

    November 1 2008

    End Date

    December 1 2015

    Last Update

    May 15 2019

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Maastro Lab at University of Maastricht

    Maastricht, Netherlands, 6200MD

    2

    Kantonsspital Aarau

    Aarau, Switzerland, CH-5001

    3

    Universitaetsspital-Basel

    Basel, Switzerland, CH-4031

    4

    Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    Bellinzona, Switzerland, CH-6500