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Completed

NCT Number: NCT01456156

Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma

Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.

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Key information

Conditions

Hepatocellular Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Postoperative Radiotherapy

Radiation

IMRT or 3DCRT, 50-60Gy to the tumor bed

Other names: adjuvant radiotherapy

Primary outcomes

  1. overall survival

    Time frame: 3 year

    the rate of overall survival for 3 year

Secondary outcomes

  1. local recurrence free survival

    Time frame: 3 years

    the rate of local recurrence free survival for 3 years

  2. disease free survival

    Time frame: 3 years

    the rate of disease free survival for 3 years

  3. Number of Participants with Adverse Events

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2011
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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