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RadiotherapyCkvsmalmNCT03963726

Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer.

A study testing stereotactic radiotherapy and microwave alabation in people with Radiotherapy and Microwave Ablation, run by Peking University Third Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Data of 100 colorectal cancer patients with liver metastases who received stereotactic radiotherapy of Cyberknife or microwave ablation in the multicenter of the research group from June 2019 to May 2021 were collected, as well as follow-up data.To evaluate the clinical efficacy of stereotactic radiotherapy and… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Radiotherapy, Microwave Ablation, Liver Metastases
What is being tested?
stereotactic radiotherapy and microwave alabation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesChina
Study dates
3 Jun 2019to 31 May 2022
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The age was 18 to 80 years old.
  • It was confirmed by pathology that the liver metastasis of colorectal cancer was less than or equal to 3 lesions, each lesion was less than 3 cm, and there was no invasion of vascular tumor thrombus and adjacent organs according to the discussion of MDT.
  • The preoperative imaging evaluation of iatrogenic or / and personal factors can realize microwave ablation or radiosurgery SBRT to require.
  • The primary lesion has been treated radical and has no evidence of recurrence, and there is no metastasis outside the liver.
  • The physical status score of ECOG : 0 ≥ 1 or more than 60 KPS.
  • Predicted survival time was more than 3 months.
Show all 13Show fewer
  • The main organ function can tolerate stereotactic radiotherapy / microwave ablation, liver function child-pugh A or B, no severe hypertension, diabetes and heart disease. That is, within 14 days of random examination, the relevant test indexes meet the following requirements:
  • blood routine examination: i. Hemoglobin was more than 90 g /L (no blood transfusion); ii. Neutrophil count was more than 1.5x109/L; iii platelet count was more than 100x109/ L;
  • biochemical examination: i. total cholerythrin-1.5-ultraln (upper limit of normal); ii. Blood-valley-pyruvic transaminase (ALT) or blood-glutamic-aspartate aminotransferase (AST), 2.5-hulled; iii. The clearance of endophytic muscle was 60 ml/ min (ckroft-gault formula);
  • cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) was more than 50%;
  • blood glucose control was less than 7.2 mmol/ L, non-fasting blood glucose was less than 10 mmol/L, and glycosylated hemoglobin was less than 7%.
  • Sign informed consent form.
  • Good compliance, family agreed to cooperate with follow-up.

Who cannot join

  • Patients who are being treated with drugs and whose liver metastases are stable or relieved, and who have participated in clinical trials of other drugs within four weeks;
  • There was a history of bleeding, and any serious bleeding events of 3 degrees or more in ctcae 5.0 occurred within 4 weeks before screening.
  • Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with suspected central nervous system metastasis, CT or MRI examination must be performed within 14 days before randomization to exclude central nervous system metastasis.
  • Patients with high blood pressure and single step-down medications were not able to obtain good control (systolic blood pressure was more than 140 mmHg, diastolic blood pressure was more than 90 mmHg); patients with a history of unstable angina; a new diagnosis within 3 months before screening was an event of myocardial infarction within 6 months before or after screening; Arrhythmias (including QTCF: male,450 ms, female, 470ms) require long-term use of anti-arrhythmic drugs and the New York Heart Association rating of grade ii cardiac insufficiency;
  • Long-term unhealed wounds or incomplete fractures,
  • Imaging showed that the tumor had invaded the perivascular area of important vessels or was judged by researchers that the tumor was highly likely to invade important blood vessels during treatment, resulting in fatal massive bleeding.
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  • Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must be satisfied:INR is within the normal range without anticoagulant); Patients treated with anticoagulant or vitamin k antagonists such as warfarin, heparin or its analogues; Low dose warfarin (1mg oral, once a day) or low dose aspirin (not exceeding 100 mg); per day) is allowed for prophylactic purposes on the premise that the international standardized ratio of prothrombin time (INR) was less than 1.5;
  • Hyperarteriovenous thrombosis occurred within 6 months before screening, such as cerebrovascular accidents (including temporary ischemic seizures), Deep venous thrombosis (except where venous thrombosis caused by intravenous catheterization after pre-chemotherapy has been cured by researchers) and pulmonary embolism, etc.
  • There was abnormal thyroid function in the past, and even in the case of drug treatment, thyroid function could not be maintained within the normal range;
  • Having a history of psychotropic substance abuse and unable to give up or have mental disorders.
  • Radiotherapy for abdominal tumors has been carried out in the past.
  • Have a history of immunodeficiency, or suffer from other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation.
  • According to the researchers' judgment, there are serious diseases that endanger the safety of patients or affect the completion of the study.

Trial locations and contacts

6 sites in 1 country.

Junjie U Wang, MD contact

+8682264910 ext. +8682264910

junjiewang_edu@sina.cn

Fei U Xu, M Med contact

+8618511866032 ext. +8682264910

xufeibysy@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Ditan Hospital

    Beijing, Beijing Municipality, 100000

    Wei Li, MD

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

    Junjie Wang, Chairman, +8682264910, junjiewang_edu@sina.cn

    Fei Xu, +8618511866032, xufeibysy@163.com

    Recruiting

  • The fifth medical center of PLA general hospital

    Beijing, Beijing Municipality, 100000

    Xuezhang Duan, director, +8613621386161, 13621386161@163.com

    Xuezhang Duan

    Recruiting

  • Hunan Aerospace Hospital

    Changsha, Hunan, 410205

    Xian Xu, MD

    Recruiting

  • Guangxi ruikang hospital

    Nanning, Guangxi, 530000

    ZuPing Lian, M Med

    Recruiting

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong, 277599

    Kaixian Zhang, director, +8613563200960, kaixianzhang@aliyun.com

    Kaixian Zhang, director

    Recruiting

Other trials in China

About this study

Official title: Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer: a Prospective Multicenter Cohort Study

Data of 100 colorectal cancer patients with liver metastases who received stereotactic radiotherapy of Cyberknife or microwave ablation in the multicenter of the research group from June 2019 to May 2021 were collected, as well as follow-up data.To evaluate the clinical efficacy of stereotactic radiotherapy and microwave ablation in liver metastases.In addition, the local control rate and side effects of stereotactic radiotherapy and microwave ablation in the treatment of liver metastases were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined.

Read the detailed description

In the study，data of 100 colorectal cancer patients with liver metastases who received Cyberknife stereotactic radiotherapy or microwave ablation in the multi-center of the research group from June 2019 to May 2021 were collected, as well as follow-up data.

  1. Radiation: Stereotactic Radiotherapy 1.1 Equipment: Accuray VSI Cyberknife stereotactic radiotherapy platform, simulated positioning CT machine, MR, positron emission computed tomography PET-CT, vacuum pad. 1.2 Radiotherapy localization: CT, MRI and PETCT were used to simulate localization. 1.3 Relevant Definitions of Tumor Targets CT, MRI, PET-CT fusion, combined with MRI location and PET-CT location image for sketching. To delineate target areas and organs at risk. GTV: Combining localization and fusion images to delineate the tumors seen PTV = GTV + 0-10mm Dangerous organs: The stomach, duodenum, jejunum, ileum, colon, spinal cord and esophagus were delineated on the base sequence of CT plain scan. The target area should be approved by at least one physician in charge or by a physician in charge. 1.4 Target volume radiation dose: According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10). 1.5 Normal Tissue Limit: Reference to TG101 Report
  2. Microwave ablation 2.1 Preoperative positioning and planning: 2.1.1 Determine the fixing device: generally choose vacuum pad to fix 2.1.2 Choosing the right position: The principle is to choose the position that is easy to operate, taking into account the comfort and tolerance of patients.

2.1.3 CT scan 2.1.4 The range of tumors was determined by CT images. In principle, at the maximum level, the skin points corresponding to the vertical center of the tumor are the marker points of the locating needle. At the same time, the center of the tumor was taken as the origin point, and the longitudinal and transverse cross lines were drawn on the patient's body surface. Roughly delineate the range of tumors according to CT in body surface 2.2 Surgery and intraoperative optimization 2.2.1 Posture reduction and fixation of patients 2.2.2 Oxygen inhalation, ECG and blood pressure monitoring 2.2.3 Installation of 3D Printing Planar Coordinate Template Fixer 2.2.4 Routine disinfection, cave towel laying, local infiltration anesthesia, fixing 3D printing plane coordinate template according to the range of tumors determined by physical examination and preoperative plan, and adjusting the direction of plane template by protractor.

2.2.5 Puncture locating needle and puncture assistant fixing needle in 4 directions of tumor margin.

2.2.6The real-time CT 2.5mm image was imported into the navigation system, the puncture needle was marked, the puncture needle was simulated, and the resolution of the template was adjusted accurately.

2.2.7 Enhanced CT scan to determine the position and angle of template and pin accurately 2.2.8 Layer by layer puncture according to preoperative plan 2.2.9 After inserting the ablation antenna to the reserved position, scan CT again to confirm whether the puncture needle has reached the planned position. 2.2.10 Complete ablation of tumors as planned.

2.3Postoperative observation 2.3.1 With the assistance of the staff in the hospital, they will be transported back to the ward by flat car with their families.

2.3.2 Re-measurement of blood pressure and heart rate 2.3.3Observe whether there is bleeding or exudation at the puncture point after operation, and give hemostasis and pain relief if necessary.

To evaluate the clinical efficacy of stereotactic radiotherapy and microwave ablation in liver metastases after these treatment.In addition, the local control rate and side effects of stereotactic radiotherapy and microwave ablation in the treatment of liver metastases were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined.

Being tested
stereotactic radiotherapy, microwave alabation
Keywords
Radiotherapy, microwave ablation, Liver Metastases, Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stereotactic radiotherapyRadiation

    The liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).

  • microwave alabationOther

    The colorectal cancer patients with liver metastases will receive microwave ablation.3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.

Study groups in NCT03963726
Study groupRoleWhat they receive
Stereotactic radiotherapyExperimentalIn this study, the liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
Receives: Radiation: stereotactic radiotherapy
Microwave ablation therapyExperimentalIn this study, 3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.
Receives: Other: microwave alabation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control rate

    Local control refers to the fact that the tumor is not enlarged on imaging, but if the tumor is not enlarged, the patients with aggravated symptoms after treatment are not included in the local control range.

    Measured: 3 years after the treatment

  2. Objective response rate

    The proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including CR + PR cases

    Measured: 1 years after the treatment

  3. Disease control rate

    After treatment, the number of cases with remission and stable lesions accounted for the percentage of the total number of assessable cases

    Measured: 3 years after the treatment

  4. PFS

    The time interval of disease progression since the date of diagnosis

    Measured: 3 years after the treatment

Secondary outcomes (3)

  1. Overall survival

    The time from enrollment to death from any cause

    Measured: 3 years after the treatment

  2. Side effects

    Harmful reactions unrelated to the purpose of treatment occur in the course of the treatment of a disease

    Measured: 1 years after the treatment

  3. Quality of life score of tumor patients(0-60)

    Common methods for evaluating the quality of life of patients:The full score of quality of life is 60, the worst is < 20, the worse is 21-30, the average is 31-40, the better is 41-50, and the good is 51-60.

    Measured: 3 years after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start3 Jun 2019
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 May 2022 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
non-randomized trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03963726
Sponsor's protocol ID
BYSY-CKMA-LM
Acronym
Ckvsmalm
Status last verified
May 2019
First submitted
21 May 2019
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan ZY, Meng MB, Liu CL, Wang HH, Jiang C, Song YC, Zhuang HQ, Yang D, Wang JS, Wei W, Li FT, Zhao LJ, Wang P. Stereotactic body radiation therapy using the CyberKnife((R)) system for patients with liver metastases. Onco Targets Ther. 2014 Jun 12;7:915-23. doi: 10.2147/OTT.S58409. eCollection 2014.

    PubMed 24959080

  • Mihara K, Kaihara M, Sunahori S, Yamashiro N, Nishiya S, Ito Y, Funakoshi K, Egawa T, Tsukamoto N, Nagashima A. [Stereotactic Body Radiotherapy with CyberKnife(R)for Liver Metastases from Colorectal Cancer]. Gan To Kagaku Ryoho. 2015 Oct;42(10):1262-4. Japanese.

    PubMed 26489566

  • Kress MS, Collins BT, Collins SP, Dritschilo A, Gagnon G, Unger K. Stereotactic body radiation therapy for liver metastases from colorectal cancer: analysis of safety, feasibility, and early outcomes. Front Oncol. 2012 Feb 2;2:8. doi: 10.3389/fonc.2012.00008. eCollection 2012.

    PubMed 22649775

  • Dewas S, Bibault JE, Mirabel X, Fumagalli I, Kramar A, Jarraya H, Lacornerie T, Dewas-Vautravers C, Lartigau E. Prognostic factors affecting local control of hepatic tumors treated by Stereotactic Body Radiation Therapy. Radiat Oncol. 2012 Oct 10;7:166. doi: 10.1186/1748-717X-7-166.

    PubMed 23050794

  • Herfarth KK, Debus J, Wannenmacher M. Stereotactic radiation therapy of liver metastases: update of the initial phase-I/II trial. Front Radiat Ther Oncol. 2004;38:100-5. doi: 10.1159/000078271. No abstract available.

    PubMed 15458194

  • Mendez 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 16982547

  • Hoyer M, Roed H, Traberg Hansen A, Ohlhuis L, Petersen J, Nellemann H, Kiil Berthelsen A, Grau C, Aage Engelholm S, Von der Maase H. Phase II study on stereotactic body radiotherapy of colorectal metastases. Acta Oncol. 2006;45(7):823-30. doi: 10.1080/02841860600904854.

    PubMed 16982546

  • Lee MT, Kim JJ, Dinniwell R, Brierley J, Lockwood G, Wong R, Cummings B, Ringash J, Tse RV, Knox JJ, Dawson LA. Phase I study of individualized stereotactic body radiotherapy of liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1585-91. doi: 10.1200/JCO.2008.20.0600. Epub 2009 Mar 2.

    PubMed 19255313

  • Lanciano R, Lamond J, Yang J, Feng J, Arrigo S, Good M, Brady L. Stereotactic body radiation therapy for patients with heavily pretreated liver metastases and liver tumors. Front Oncol. 2012 Mar 9;2:23. doi: 10.3389/fonc.2012.00023. eCollection 2012.

    PubMed 22645716

  • Ambrosino G, Polistina F, Costantin G, Francescon P, Guglielmi R, Zanco P, Casamassima F, Febbraro A, Gerunda G, Lumachi F. Image-guided robotic stereotactic radiosurgery for unresectable liver metastases: preliminary results. Anticancer Res. 2009 Aug;29(8):3381-4.

    PubMed 19661360

  • Rusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.

    PubMed 19255321

  • Katz 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 17197128

  • Yamashita H, Onishi H, Matsumoto Y, Murakami N, Matsuo Y, Nomiya T, Nakagawa K; Japanese Radiological Society multi-institutional SBRT study group (JRS-SBRTSG). Local effect of stereotactic body radiotherapy for primary and metastatic liver tumors in 130 Japanese patients. Radiat Oncol. 2014 May 10;9:112. doi: 10.1186/1748-717X-9-112.

    PubMed 24886477

  • Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.

    PubMed 20879569

  • Groeschl RT, Pilgrim CH, Hanna EM, Simo KA, Swan RZ, Sindram D, Martinie JB, Iannitti DA, Bloomston M, Schmidt C, Khabiri H, Shirley LA, Martin RC, Tsai S, Turaga KK, Christians KK, Rilling WS, Gamblin TC. Microwave ablation for hepatic malignancies: a multiinstitutional analysis. Ann Surg. 2014 Jun;259(6):1195-200. doi: 10.1097/SLA.0000000000000234.

    PubMed 24096760

Questions about this trial

What is this clinical trial studying?

A study testing stereotactic radiotherapy and microwave alabation in people with Radiotherapy and Microwave Ablation, run by Peking University Third Hospital at 6 sites 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 13 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

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 Junjie U Wang, MD (+8682264910 ext. +8682264910, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control rate (time frame: 3 years after the treatment). The study lists 4 primary outcomes in all. 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 NCT03963726, 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 19 Jul 2019.

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