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

NCT03963726 | Unknown

• 1 other identifier: BYSY-CKMA-LM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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 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.

Conditions

Radiotherapy; Microwave Ablation; Liver Metastases; Colorectal Cancer

Keywords

Radiotherapy; microwave ablation; Liver Metastases; Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  3 years after the treatment

• 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

  1 years after the treatment

• 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

  3 years after the treatment

• PFS

  The time interval of disease progression since the date of diagnosis

  3 years after the treatment

Secondary Outcomes (3)

• Overall survival

  3 years after the treatment

• Side effects

  1 years after the treatment

• Quality of life score of tumor patients(0-60)

  3 years after the treatment

Study Arms (2)

Stereotactic radiotherapy

EXPERIMENTAL

In 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).

Radiation: stereotactic radiotherapy

Microwave ablation therapy

EXPERIMENTAL

In 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.

Other: microwave alabation

Interventions

stereotactic radiotherapy RADIATION

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).

Stereotactic radiotherapy

microwave alabation OTHER

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.

Microwave ablation therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing 302 Hospital: collaborator
• Tengzhou Central People's Hospital: collaborator
• Guangxi Ruikang Hospital: collaborator
• Hunan Aerospace Hospital: collaborator
• Beijing Ditan Hospital: collaborator

Study Sites (6)

Beijing Ditan Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The fifth medical center of PLA general hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Guangxi ruikang hospital

Nanning, Guangxi, 530000, China

RECRUITING

Hunan Aerospace Hospital

Changsha, Hunan, 410205, China

RECRUITING

Tengzhou Central People's Hospital

Tengzhou, Shandong, 277599, China

RECRUITING

Related Publications (16)

• 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.

  PMID: 24959080 BACKGROUND

• 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.

  PMID: 26489566 BACKGROUND

• 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.

  PMID: 22649775 BACKGROUND

• 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.

  PMID: 23050794 BACKGROUND

• 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.

  PMID: 15458194 BACKGROUND

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  PMID: 16982547 BACKGROUND

• 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.

  PMID: 16982546 BACKGROUND

• 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.

  PMID: 19255313 BACKGROUND

• 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.

  PMID: 22645716 BACKGROUND

• 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.

  PMID: 19661360 BACKGROUND

• 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.

  PMID: 19255321 BACKGROUND

• 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.

  PMID: 17197128 BACKGROUND

• 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.

  PMID: 24886477 BACKGROUND

• 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.

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• 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.

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• Xu S, Hu K, Huang H, Yao Z, Wang Q, Yang P, Liu B, Yang Y, Chen G. [Effect of laparoscopic hepatectomy and microwave ablation for colorectal liver metastases]. Zhonghua Yi Xue Za Zhi. 2015 Oct;95(40):3289-92. Chinese.

  PMID: 26815350 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Junjie U Wang, MD

  Peking University Third Hospital

  STUDY CHAIR

• Fei U Xu, M Med

  Peking University Third Hospital

  STUDY DIRECTOR

• Xuezhang Duan, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Kaixian Zhang, MD

  Tengzhou Central People's Hospital

  PRINCIPAL INVESTIGATOR

• Wei Li, MD

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

• Hui Xie, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Zuping Lian, MD

  Guangxi Ruikang Hospital

  PRINCIPAL INVESTIGATOR

• Xian Xu, M Med

  Hunan Aerospace Hospital

  PRINCIPAL INVESTIGATOR

• Fuxin Guo, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Jing Sun, M Med

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junjie U Wang, MD

CONTACT

+8682264910; junjiewang_edu@sina.cn

Fei U Xu, M Med

CONTACT

+8618511866032; xufeibysy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized trial

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 28, 2019
• Study Start: June 3, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)