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

Swiss Group for Clinical Cancer Research

Status and phase

Completed

Phase 2

Phase 1

Conditions

Liver Cancer

Treatments

Radiation: 3-dimensional conformal radiation therapy

Radiation: stereotactic body radiation therapy

Radiation: intensity-modulated radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00777894

EU-20884

SAKK 77/07

SWS-SASL-26

SWS-SAKK-77/07

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)