Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

NCT01668134 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 09-1345 / 201107319
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.

Conditions

Carcinoma, Hepatocellular; Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.

  Up to 90 days after end of radiation therapy

Secondary Outcomes (4)

• Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.

  Up to 60 days after end of radiation therapy

• Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.

  Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease

• Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.

  Baseline to time of death

• Measure the response rates associated with using SBRT in patients with resectable HCC and IHC

  Baseline to the first date of recurrance or progressive disease

Study Arms (1)

Stereotactic radiation

EXPERIMENTAL

Radiation: Stereotactic radiation

Interventions

Stereotactic radiation RADIATION

Stereotactic radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Karnofsky Performance Status of ≥ 60
• Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
• or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
• Local surgical resection is not possible due to tumor or patient factors
• Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
• Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
• Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
• Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
• Able to provide signed informed consent

You may not qualify if:

• Childs-Pugh score 9 or more
• ALT or AST ≥ 6 x upper limit of normal
• Prior history of abdominal irradiation
• Women who are pregnant or nursing
• Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
• Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
• Undergone prior radiation therapy to the abdomen.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Parag Parikh, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 17, 2012
• Study Start: December 16, 2009
• Primary Completion: August 30, 2014
• Study Completion: December 22, 2015
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)