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Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Cancer

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Trial Information

Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study


Patients with risk factors of recurrence receive postoperative radiotherapy using intensive
modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT).
The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall
survival, local-recurrence free survival, disease free survival and toxicity need be
observed.


Inclusion Criteria:



- written informed consent provided

- 18~75 years old

- patients with histopathological proved hepatocellular carcinoma received hepatectomy
and had at least one risk factor of recurrence

- without any lymph node or distant metastasis (any T N0M0)

- liver function: Child-Pugh A or B

- Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1

- life expectation>6 months

- no dysfunction of major organs

- no prior radiotherapy

- negative for human immunodeficiency virus syndrome (HIV)

- Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT

Exclusion Criteria:

- malignant tumors of other sits

- combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias,
infection

- surgery performed in other hospitals without details

- pregnant woman or woman need to breast feed or woman with positive chorionic
gonadotrophin (HCG)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

the rate of overall survival for 3 year

Outcome Time Frame:

3 year

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

CH-GI-019

NCT ID:

NCT01456156

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Hepatocellular Cancer
  • hepatocellular carcinoma
  • postoperative radiotherapy
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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