Neoplasms

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Liver Diseases

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Liver Extracts

Resection of both primary and secondary tumors in SCRLM and resection of MCRLM. Interventions: Simultaneous resection of both primary and secondary tumors in SCRLM and resection of MCRLM.

Ablation of CRLM after resection of primary tumor in SCRLM and ablation of MCRLM.

Interventions: Ablation of liver metastasis within 30 days after resection of primary tumor in SCRLM and ablation of MCRLM.

Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.

CRLM resection group

Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.

CRLM ablation group

Meijin Huang, MD,PHD

Jun Huang, MD,PHD

The surgical and local ablation strategy for the treatment of resectable synchronous and metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of this study is to compare two treatment strategies in which simultaneous resection of both primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.

Colorectal cancer(CRC) kills more than 700,000 patients every year, which is nowadays the world's 3rd common and the 4th deadly tumor. About 50% CRC patients will finally develop colorectal liver metastasis (CRLM). Among the CRLM patients, 20-25% of CRC are found with synchronous colorectal liver metastases (SCRLM) at the first visit. Meanwhile, about 20-30% CRC patients suffer by metachronous colorectal liver metastasis (MCRLM) even after radical resection of primary tumor. It is nowadays admitted that the R0 resection of both primary and secondary tumors in SCRLM and R0 resection of MCRLM represents a feasible and potential curative treatment in patients with resectable CRLM(RCRLM). However, the treatment strategy for some RCRLM (tumor number≤3 and tumor size≤3.0cm), such as whether to choose hepatectomy or local ablation, still remains in debate. In primary hepatocellular carcinoma(HCC), local ablation has been proved to has similar curative effect to that of hepatectomy. Compared to hepatectomy, local ablation has less trauma and more rapid recovery and possible lower hospitalization cost. The curative effect of local ablation is mainly influenced by tumor site and tumor size. On the other side, some RCRLM might develop repeat recurrences even after "R0" resection due to the imaging undetectable micro metastasis. Thus, local ablation might be more suitable for some repeat recurrent CRLM. The aim of this study is to compare the efficacy/safety of local ablation with hepatectomy for RCRLM (tumor number≤3, tumor size≤3.0cm), including both SCRLM and MCRLM. Patients are randomized to CRLM resection group and local ablation group. The primary endpoint is overall survival. Secondary endpoints evaluate the rate of patients with at least one severe complication within 30 days after surgery/ablation and long-term clinical outcomes, in particular disease-free survival.

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study

First Affiliated Hospital, Sun Yat-Sen University

Second Affiliated Hospital, Sun Yat-Sen University

Sixth Affiliated Hospital, Sun Yat-sen University

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Prostatic Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Kidney Neoplasms

Neoplasms, Second Primary

Brain Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Urologic Neoplasms

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Urologic Diseases

Adenocarcinoma

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Malignant Mesothelioma

Vasoconstrictor Agents

Respiratory System Agents

Gastrointestinal Agents

Epinephrine

Pancrelipase

Racepinephrine

Epinephryl borate

Pancreatin

SMART will be administered per each individual disease site standards

Radiation will be delivered on an MR-guided Linear Accelerator

MR-guided Linac

Jonathan Leeman, MD

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.

* The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
* Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.

The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.

In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete.

Stereotactic Magnetic Resonance Guided Radiation Therapy

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Dr. Jonathan Leeman (jonathane_leeman@dfci.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Enrolling patients and delivering SMART on the MR Linac

Assessing tumor using MR guidance before, during and after MR-guided treatment patient

Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

Duration of treatment with goal of \>80% of cases treated within 90 minutes

Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

assessing long-term (12 month) toxicity in patients receiving SMART

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis	NCT02886104	Secondary Malig...	CRLM resection ... CRLM ablation g...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis	NCT02886104	Secondary Malig...	CRLM resection ... CRLM ablation g...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis	NCT02886104	Secondary Malig...	CRLM resection ... CRLM ablation g...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Stereotactic Magnetic Resonance Guided Radiation Therapy	NCT04115254	Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metasta... Prostate Cancer Liver Metastase... Oligoprogressiv... Metachronous No... Synchronous Nod... Mesothelioma Spine Metastase... Brain Metastase... Borderline Rese...	MR-guided Linac	18 Years -	Dana-Farber Cancer Institute
Stereotactic Magnetic Resonance Guided Radiation Therapy	NCT04115254	Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metasta... Prostate Cancer Liver Metastase... Oligoprogressiv... Metachronous No... Synchronous Nod... Mesothelioma Spine Metastase... Brain Metastase... Borderline Rese...	MR-guided Linac	18 Years -	Dana-Farber Cancer Institute
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis	NCT02886104	Secondary Malig...	CRLM resection ... CRLM ablation g...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University

Spots Global Cancer Trial Database for metachronous

Every month we try and update this database with for metachronous cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.