A phase I dose escalation study of concurrent chemoradiotherapy in patients with unresectable hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002644

Enrollment

Registered

2018-01-09

Start date

2015-07-28

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : First, the fractional dose is set at 2.1 Gy, and the total dose is planned to be 52.5 Gy in 3 patients. If one or two patients in the first three patients reach dose-limiting toxicity, add

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unresectable primary liver cancer 2. Age = 20 years 3. Whole body performance (ECOG) 0-2 4. Liver cirrhosis has a Child-Pugh score of 5-7 5. Minimum volume of normal liver without tumor invasion> 800 cc 6. Minimal distance between target (PTV1) and organ at risk (eg. duodenum, stomach) = 0.5cm 7. Adequate renal function (creatinine 50 ml / min) 8. BM reserve (ANC =1500 / mm3, PLT =50000 / mm3, Hb> 9 g / dl) 9. A lesion that can be measured or evaluated on CT 10. Patients who are pregnant and who agree to contraception

Exclusion criteria

Exclusion criteria: 1. Patients who fail to perform respiratory training for treatment design 2. Patients with a history of previous abdominal radiation therapy 3. Patients who can not receive consent before treatment 4. Patients who do not agree to contraception as a conceived patient

Design outcomes

Primary

Measure	Time frame
Radiation-induced liver disease (RILD)	—

Secondary

Measure	Time frame
Gastrointestinal tract toxicity at Grade 4 or higher	—

Countries

Korea, Republic of

Contacts

Public ContactIk Jae Lee

Yonsei University Health System, Gangnam Severance Hospital

ikjae412@yuhs.ac+82-2-2019-3152

Outcome results