Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Recurrence

Necrosis

Neoplasms, Second Primary

Brain Neoplasms

Disease Attributes

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).

Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Post-op hypofractionated therapy or no radiation therapy

Radiation Therapy

Best medical management with steroid therapy

Steroid Therapy

Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)

Laser Interstitial Thermal Therapy

Christa Seligman

Beth Perry

Peter Fecci, MD

Wendy Jenkins

Adrian Laxton, MD

Allison Dymacek

Mark Hoeprich, MD

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.

REMASTer: REcurrent Brain Metastases After SRS Trial

Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression.

Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care.

Compare treatment approaches with respect to overall survival.

Compare treatment approaches with respect to FFLP or neurologic death

Monteris Medical

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients only accepted microwave ablation

Patients accepted microwave ablation plus lenvatinib

Microwave ablation

lenvatinib (80 mg for body no more than 60kg，120 mg for body weight \>60 kg)

Qunfnag Zhou, MD

Xiaohui Wang, MD

Xianhai Mao, Professor

This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC

Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective trial study to find out it.

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study

Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause

OS is the length of time from the date of microwave ablation until death from any cause.

Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Complication was defined as the a disease or sythrome caused by the therapy

Sun Yat-sen University

Clinical Professor

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

intraoperative radiotherapy

Sam Ngan

The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

locoregional control, progression-free and overall survival rates.

Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria

Peter MacCallum Cancer Centre, Australia

Wounds and Injuries

Body Weight

Radiation Injuries

Radiation Injury Recurrent symptoms after radiation therapy of a brain tumor are not always the result of tumor recurrence but may represent radiation necrosis of the brain.

Symptoms are the result of actual tumor recurrence

Pia M Sundgren, MD, Ph.D

The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if a brain tumor has recurred or if the person has radiation injury following their treatment.

After a patient has been treated for a brain tumor by radiation the area of the brain that has been treated changes in appearance. These changes in appearance can make it hard to determine if a brain tumor has come back at the same site or if it is radiation injury. The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury.

Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI

Prospective Study Differentiating Recurrent Brain Tumor Versus Radiation Injury Using Magnetic Resonance (MR) Spectroscopy, Diffusion Tensor Imaging and Diffusion Weighted Imaging on 3T(Tesla) MR Scanner

The purpose of this study is to determine if certain MRI imaging sequences are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury

University of Michigan

Principal Investigator

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Endothelial Growth Factors

Mitogens

Ramucirumab

Angiogenesis Inhibitors

Growth Inhibitors

(Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.

(Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

A Phase 1 Study Of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors, Including CNS Tumors

A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:

1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT.

8. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.

Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.

Children's Oncology Group

Eli Lilly and Company

All randomized participants who received at least one dose of study drug.

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.

8 mg/kg Ramucirumab (Part A)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

12 mg/kg Ramucirumab (Part A)

12 mg/kg Ramucirumab (Part B)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Chief Medical Officer

All randomized participants from Part A, who received at least one dose of study drug.

Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab

Cycle 1 Day 1

Cycle 1 Day 43

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.

8 mg/kg Ramucirumab

12 mg/kg Ramucirumab

All randomized participants who received at least one dose of study drug and had evaluable PK data. Per protocol, 12 mg/kg Ramucirumab PK data were reported per dose level combining Part A and B participants.

Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Number of Participants With Anti-Ramucirumab Antibodies

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)

Zero participants analyzed. Duration of response was not evaluable, as there were no participants with CR or PR.

Duration of Response (DOR)

Overall Survival

Participants received 8 milligram per kilogram \[mg/kg\] Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REMASTer: REcurrent Brain Metastases After SRS Trial	NCT05124912	Brain Metastase... Radiation Necro... Recurrent Tumor Recurrent Metas...	Radiation Thera... Steroid Therapy Laser Interstit...	18 Years -	Monteris Medical
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma	NCT05444478	Hepatocellular ... Microwave Ablat... Liver Cancer Lenvatinib Recurrent Tumor	Microwave ablat... Lenvatinib	18 Years - 75 Years	Sun Yat-sen University
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer	NCT01493206	Malignant Recta... Recurrent Tumor	intraoperative ...	18 Years -	Peter MacCallum Cancer Centre, Australia
Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI	NCT00760409	Radiation Injur... Brain Tumor		18 Years -	University of Michigan
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer	NCT01493206	Malignant Recta... Recurrent Tumor	intraoperative ...	18 Years -	Peter MacCallum Cancer Centre, Australia
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors	NCT02564198	Pediatric Solid... Refractory Tumo... Recurrent Tumor CNS Malignancie...	Ramucirumab	12 Months - 21 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for recurrent tumor