Liver NeoplasmsPhase 2NCT02363218
Study on Effectiveness and Safety of Hepatocellular Carcinoma Patients Treated With CyberKnife
A Phase 2 study testing CyberKnife in people with Liver Neoplasms, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall survival for HCC patients treated with CyberKnife SBRT at 2 years. Secondary Objective(s): 1) To determine overall survival for HCC patients treated with CyberKnife SBRT at 1 year 2) To determine local control using RECIST and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- CyberKnife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed hepatocellular carcinoma according to one of three EASL criteria:
- Histopathology
- Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion >2 cm with arterial hypervascularization
- One radiographic technique that confirms a lesion >2 cm with arterial hypervascularization and an AFP>400 ng/mL
- Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
- Volumn of uninvolved liver >750 cc
Show all 18Show fewer
- Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
- Patients with liver disease classified as Child Pugh class A
- Life expectancy >6 months
- Age > 18 years old
- Albumin > 2.5 g/dL
- Total Bilirubin < 3 mg/dL
- INR <1.5
- Transaminases (SGOT and SGPT) no more than 3 times the upper limit of normal
- Creatinine < 2.0 mg/dL
- Both men and women and members of all races and ethnic groups are eligible for this study
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior surgery, chemotherapy or radiation for the liver tumor
- Prior radiotherapy to the upper abdomen
- Prior RFA or liver transplant
- Tumors greater than 5 cm in greatest axial dimension
- Child B status
- Contraindication to receiving radiotherapy
Show all 13Show fewer
- Active gastrointestinal bleed within 2 weeks of study enrollment
- Clinically significant ascites refractory to medical therapy
- Women who are pregnant
- Administration of any systemic chemotherapy within the last 6 months
- Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
- Portal vein thrombus
- Participation in another concurrent treatment protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: An Open-Label, Multi-Center, Single-Arm Study on Effectiveness and Safety of Stereotactic Body Radiotherapy (SBRT) Treating Hepatocellular Carcinoma Patients With CyberKnife
Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall survival for HCC patients treated with CyberKnife SBRT at 2 years.
Secondary Objective(s): 1) To determine overall survival for HCC patients treated with CyberKnife SBRT at 1 year 2) To determine local control using RECIST and EASL criteria at 1 and 2 years 3) To assess progression-free survival at 1 and 2 years 4) To assess acute and late toxicities following CyberKnife SBRT.
Read more
Hypothesis: Overall survival rate of HCC patients at one year after SBRT treatment is not less than 65%.
Study Design: Single arm study. Patients will undergo a CT scan with and without contrast and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions within a 7 day window at the discretion of the investigator.
Sample size: The sample size required is 93 with a power of 90%, p=0.05, 50% response rate is considered not effective (p0) and 65% overall survival rate at 1 year (p1) is considered effectiveness of the treatment. The estimated drop-out rate is 20%, so the total sample size would be 117.
Statistical Considerations: The set of Intention-To-Treat (ITT) will be analyzed. All patients will be censored at their last visit, including the patients lost to follow-up. All patients will be followed and counted in the therapy to which they were assigned, even if they decline that therapy. Only those patients who refuse (in writing) to have their outcomes count in the study's conclusions will not be included in the analyses from that time forward; however, the follow-up data for such patients will be included up until the time they withdraw consent. Such patients will be replaced.
Baseline characteristics of patients will be presented with summary statistics. Time-to-event survival rates for OS and DFS will be estimated using the Kaplan-Meier method and presented at one and/or two years. The incidence of acute and late toxicities will be presented in tabular form on both a per-patient and per-event basis.
Read the detailed description
Indication: Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates.
The investigators propose to conduct a Phase II study assessing the efficacy and safety of CyberKnife SBRT for the treatment of HCC.
Summary of Subject Eligibility Criteria:
Inclusion Criteria
- Confirmed hepatocellular carcinoma according to one of three EASL criteria:
- Histopathology
- Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion >2 cm with arterial hypervascularization
- One radiographic technique that confirms a lesion >2 cm with arterial hypervascularization and an AFP>400 ng/mL
- Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
- Volumn of uninvolved liver >750 cc
- Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
- Patients with liver disease classified as Child Pugh class A
- Life expectancy >6 months
- Age > 18 years old
- Albumin > 2.5 g/dL
- Total Bilirubin < 3 mg/dL
- INR <1.5
- Transaminases (SGOT and SGPT) no more than 3 times the upper limit of normal
- Creatinine < 2.0 mg/dL
- Both men and women and members of all races and ethnic groups are eligible for this study
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document Exclusion Criteria
- Prior surgery, chemotherapy or radiation for the liver tumor 2. Prior radiotherapy to the upper abdomen 3. Prior RFA or liver transplant 4. Tumors greater than 5 cm in greatest axial dimension 5. Child B status 6. Contraindication to receiving radiotherapy 7. Active gastrointestinal bleed within 2 weeks of study enrollment 8. Clinically significant ascites refractory to medical therapy 9. Women who are pregnant 10. Administration of any systemic chemotherapy within the last 6 months 11. Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases 12. Portal vein thrombus 13. Participation in another concurrent treatment protocol Intervention and Mode of Delivery: CyberKnife SBRT - External photon radiation. Procedure is outpatient. Synchrony Respiratory Tracking System Duration of Intervention and Evaluation: The duration of treatment will be 1 week.. The follow-up period will be for 3 years following completion of therapy.
- Conditions
- Liver Neoplasms
- Being tested
- CyberKnife
- Keywords
- Liver Neoplasms, Stereotactic Body Radiotherapy, CyberKnife
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnifeRadiation
Patients will undergo a CT scan with and without contrast and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions within a 7 day window at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife | Experimental | Hepatocellular Carcinoma Patients Treated With CyberKnife Receives: Radiation: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: Two years
Secondary outcomes (3)
Overall survival rate
Measured: One year
Local Control rate
Measured: Two years
Progression-free survival
Measured: One-Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PING WANG, MD.PHD, Principal investigator, Tianjin Medical University Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363218
- Sponsor's protocol ID
- Ping Wang
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
PubMed 16250051Bruix J, Hessheimer AJ, Forner A, Boix L, Vilana R, Llovet JM. New aspects of diagnosis and therapy of hepatocellular carcinoma. Oncogene. 2006 Jun 26;25(27):3848-56. doi: 10.1038/sj.onc.1209548.
PubMed 16799626Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70. doi: 10.3109/02841869509127197.
PubMed 7576756Cardenes HR, Price TR, Perkins SM, Maluccio M, Kwo P, Breen TE, Henderson MA, Schefter TE, Tudor K, Deluca J, Johnstone PA. Phase I feasibility trial of stereotactic body radiation therapy for primary hepatocellular carcinoma. Clin Transl Oncol. 2010 Mar;12(3):218-25. doi: 10.1007/s12094-010-0492-x.
PubMed 20231127Fuss M, Salter BJ, Herman TS, Thomas CR Jr. External beam radiation therapy for hepatocellular carcinoma: potential of intensity-modulated and image-guided radiation therapy. Gastroenterology. 2004 Nov;127(5 Suppl 1):S206-17. doi: 10.1053/j.gastro.2004.09.035.
PubMed 15508086Herfarth KK, Hof H, Bahner ML, Lohr F, Hoss A, van Kaick G, Wannenmacher M, Debus J. Assessment of focal liver reaction by multiphasic CT after stereotactic single-dose radiotherapy of liver tumors. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):444-51. doi: 10.1016/s0360-3016(03)00586-8.
PubMed 12957256Herfarth KK, Debus J, Lohr F, Bahner ML, Rhein B, Fritz P, Hoss A, Schlegel W, Wannenmacher MF. Stereotactic single-dose radiation therapy of liver tumors: results of a phase I/II trial. J Clin Oncol. 2001 Jan 1;19(1):164-70. doi: 10.1200/JCO.2001.19.1.164.
PubMed 11134209Katz AW, Carey-Sampson M, Muhs AG, Milano MT, Schell MC, Okunieff P. Hypofractionated stereotactic body radiation therapy (SBRT) for limited hepatic metastases. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):793-8. doi: 10.1016/j.ijrobp.2006.10.025. Epub 2006 Dec 29.
PubMed 17197128Kavanagh BD, Scheftera TE, Wersall PJ. Liver, renal, and retroperitoneal tumors: stereotactic radiotherapy. Front Radiat Ther Oncol. 2007;40:415-426. doi: 10.1159/000106051.
PubMed 17641524Lax I, Blomgren H, Naslund I, Svanstrom R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83. doi: 10.3109/02841869409121782.
PubMed 7946448Mendez Romero A, Wunderink W, Hussain SM, De Pooter JA, Heijmen BJ, Nowak PC, Nuyttens JJ, Brandwijk RP, Verhoef C, Ijzermans JN, Levendag PC. Stereotactic body radiation therapy for primary and metastatic liver tumors: A single institution phase i-ii study. Acta Oncol. 2006;45(7):831-7. doi: 10.1080/02841860600897934.
PubMed 16982547Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
PubMed 11668491Schefter TE, Kavanagh BD, Timmerman RD, Cardenes HR, Baron A, Gaspar LE. A phase I trial of stereotactic body radiation therapy (SBRT) for liver metastases. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1371-8. doi: 10.1016/j.ijrobp.2005.01.002.
PubMed 16029795Takeda A, Takahashi M, Kunieda E, Takeda T, Sanuki N, Koike Y, Atsukawa K, Ohashi T, Saito H, Shigematsu N, Kubo A. Hypofractionated stereotactic radiotherapy with and without transarterial chemoembolization for small hepatocellular carcinoma not eligible for other ablation therapies: Preliminary results for efficacy and toxicity. Hepatol Res. 2008 Jan;38(1):60-9. doi: 10.1111/j.1872-034X.2007.00084.x. Epub 2007 May 15.
PubMed 17506837Tse RV, Hawkins M, Lockwood G, Kim JJ, Cummings B, Knox J, Sherman M, Dawson LA. Phase I study of individualized stereotactic body radiotherapy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. J Clin Oncol. 2008 Feb 1;26(4):657-64. doi: 10.1200/JCO.2007.14.3529. Epub 2008 Jan 2.
PubMed 18172187
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Single-Arm Study on Effectiveness and Safety of Stereotactic Body Radiotherapy (SBRT) Treating Hepatocellular Carcinoma Patients With CyberKnife
- ClinicalTrials.gov ID
- NCT02363218
- Acronym / sponsor ID
- Ping Wang
- Conditions
- Liver Neoplasms
- Keywords
- Liver Neoplasms, Stereotactic Body Radiotherapy, CyberKnife
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall survival for HCC patients treated with CyberKnife SBRT at 2 years.
Secondary Objective(s): 1) To determine overall survival for HCC patients treated with CyberKnife SBRT at 1 year 2) To determine local control using RECIST and EASL criteria at 1 and 2 years 3) To assess progression-free survival at 1 and 2 years 4) To assess acute and late toxicities following CyberKnife SBRT.
Hypothesis: Overall survival rate of HCC patients at one year after SBRT treatment is not less than 65%.
Study Design: Single arm study. Patients will undergo a CT scan with and without contrast and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions within a 7 day window at the discretion of the investigator.
Sample size: The sample size required is 93 with a power of 90%, p=0.05, 50% response rate is considered not effective (p0) and 65% overall survival rate at 1 year (p1) is considered effectiveness of the treatment. The estimated drop-out rate is 20%, so the total sample size would be 117.
Statistical Considerations: The set of Intention-To-Treat (ITT) will be analyzed. All patients will be censored at their last visit, including the patients lost to follow-up. All patients will be followed and counted in the therapy to which they were assigned, even if they decline that therapy. Only those patients who refuse (in writing) to have their outcomes count in the study's conclusions will not be included in the analyses from that time forward; however, the follow-up data for such patients will be included up until the time they withdraw consent. Such patients will be replaced.
Baseline characteristics of patients will be presented with summary statistics. Time-to-event survival rates for OS and DFS will be estimated using the Kaplan-Meier method and presented at one and/or two years. The incidence of acute and late toxicities will be presented in tabular form on both a per-patient and per-event basis.
Detailed description
Indication: Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates.
The investigators propose to conduct a Phase II study assessing the efficacy and safety of CyberKnife SBRT for the treatment of HCC.
Summary of Subject Eligibility Criteria:
Inclusion Criteria
- Confirmed hepatocellular carcinoma according to one of three EASL criteria:
- Histopathology
- Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion >2 cm with arterial hypervascularization
- One radiographic technique that confirms a lesion >2 cm with arterial hypervascularization and an AFP>400 ng/mL
- Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
- Volumn of uninvolved liver >750 cc
- Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
- Patients with liver disease classified as Child Pugh class A
- Life expectancy >6 months
- Age > 18 years old
- Albumin > 2.5 g/dL
- Total Bilirubin < 3 mg/dL
- INR <1.5
- Transaminases (SGOT and SGPT) no more than 3 times the upper limit of normal
- Creatinine < 2.0 mg/dL
- Both men and women and members of all races and ethnic groups are eligible for this study
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document Exclusion Criteria
- Prior surgery, chemotherapy or radiation for the liver tumor 2. Prior radiotherapy to the upper abdomen 3. Prior RFA or liver transplant 4. Tumors greater than 5 cm in greatest axial dimension 5. Child B status 6. Contraindication to receiving radiotherapy 7. Active gastrointestinal bleed within 2 weeks of study enrollment 8. Clinically significant ascites refractory to medical therapy 9. Women who are pregnant 10. Administration of any systemic chemotherapy within the last 6 months 11. Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases 12. Portal vein thrombus 13. Participation in another concurrent treatment protocol Intervention and Mode of Delivery: CyberKnife SBRT - External photon radiation. Procedure is outpatient. Synchrony Respiratory Tracking System Duration of Intervention and Evaluation: The duration of treatment will be 1 week.. The follow-up period will be for 3 years following completion of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyberKnife | Experimental | Radiation: CyberKnifeHepatocellular Carcinoma Patients Treated With CyberKnife |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Confirmed hepatocellular carcinoma according to one of three EASL criteria:
- Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
- Volumn of uninvolved liver >750 cc
- Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
Key exclusion criteria (13 listed)
- Prior surgery, chemotherapy or radiation for the liver tumor
- Prior radiotherapy to the upper abdomen
- Prior RFA or liver transplant
- Tumors greater than 5 cm in greatest axial dimension
- Child B status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnifePatients will undergo a CT scan with and without contrast and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions within a 7 day window at the discretion of the investigator. | Radiation | CyberKnife |
Primary outcome
Overall survival rate
Time frame: Two years
3 secondary outcomes
Overall survival rate
Time frame: One year
Local Control rate
Time frame: Two years
Progression-free survival
Time frame: One-Two Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Background: PubMed 16250051Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
- Background: PubMed 16799626Bruix J, Hessheimer AJ, Forner A, Boix L, Vilana R, Llovet JM. New aspects of diagnosis and therapy of hepatocellular carcinoma. Oncogene. 2006 Jun 26;25(27):3848-56. doi: 10.1038/sj.onc.1209548.
- Background: PubMed 7576756Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70. doi: 10.3109/02841869509127197.
- Background: PubMed 20231127Cardenes HR, Price TR, Perkins SM, Maluccio M, Kwo P, Breen TE, Henderson MA, Schefter TE, Tudor K, Deluca J, Johnstone PA. Phase I feasibility trial of stereotactic body radiation therapy for primary hepatocellular carcinoma. Clin Transl Oncol. 2010 Mar;12(3):218-25. doi: 10.1007/s12094-010-0492-x.
- Background: PubMed 15508086Fuss M, Salter BJ, Herman TS, Thomas CR Jr. External beam radiation therapy for hepatocellular carcinoma: potential of intensity-modulated and image-guided radiation therapy. Gastroenterology. 2004 Nov;127(5 Suppl 1):S206-17. doi: 10.1053/j.gastro.2004.09.035.
- Background: PubMed 12957256Herfarth KK, Hof H, Bahner ML, Lohr F, Hoss A, van Kaick G, Wannenmacher M, Debus J. Assessment of focal liver reaction by multiphasic CT after stereotactic single-dose radiotherapy of liver tumors. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):444-51. doi: 10.1016/s0360-3016(03)00586-8.
- Background: PubMed 11134209Herfarth KK, Debus J, Lohr F, Bahner ML, Rhein B, Fritz P, Hoss A, Schlegel W, Wannenmacher MF. Stereotactic single-dose radiation therapy of liver tumors: results of a phase I/II trial. J Clin Oncol. 2001 Jan 1;19(1):164-70. doi: 10.1200/JCO.2001.19.1.164.
- Background: PubMed 17197128Katz AW, Carey-Sampson M, Muhs AG, Milano MT, Schell MC, Okunieff P. Hypofractionated stereotactic body radiation therapy (SBRT) for limited hepatic metastases. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):793-8. doi: 10.1016/j.ijrobp.2006.10.025. Epub 2006 Dec 29.
- Background: PubMed 17641524Kavanagh BD, Scheftera TE, Wersall PJ. Liver, renal, and retroperitoneal tumors: stereotactic radiotherapy. Front Radiat Ther Oncol. 2007;40:415-426. doi: 10.1159/000106051.
- Background: PubMed 7946448Lax I, Blomgren H, Naslund I, Svanstrom R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83. doi: 10.3109/02841869409121782.
- Background: PubMed 16982547Mendez Romero A, Wunderink W, Hussain SM, De Pooter JA, Heijmen BJ, Nowak PC, Nuyttens JJ, Brandwijk RP, Verhoef C, Ijzermans JN, Levendag PC. Stereotactic body radiation therapy for primary and metastatic liver tumors: A single institution phase i-ii study. Acta Oncol. 2006;45(7):831-7. doi: 10.1080/02841860600897934.
- Background: PubMed 11668491Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PING WANG, MD.PHD principal investigator
Tianjin Medical University Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CyberKnife in people with Liver Neoplasms, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YONGCHUN SONG, MD (8613512208919, sych1977@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363218, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.