Clinical trial · Interventional
Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.
NCT00777894CI-TRIAL-00038629completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation: 3-dimensional conformal radiation therapy
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
- Radiation: stereotactic body radiation therapy
Primary outcomes (2)
- measure
- Dose-limiting toxicity (Phase I)
- timeFrame
- during RT or within 30 days after the last RT dose, is a DLT.
- measure
- Best objective response of target liver lesions (TLLs)
- timeFrame
- according to RECIST criteria for up to 1 year after completion of study therapy (Phase II)
Secondary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (1)
- RESULTHerrmann E, Naehrig D, Sassowsky M, Bigler M, Buijsen J, Ciernik I, Zwahlen D, Pellanda AF, Meister A, Brauchli P, Berardi S, Kuettel E, Dufour JF, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). External beam radiotherapy for unresectable hepatocellular carcinoma, an international multicenter phase I trial, SAKK 77/07 and SASL 26. Radiat Oncol. 2017 Jan 13;12(1):12. doi: 10.1186/s13014-016-0745-0. PMID 28086942