Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Angiogenesis Inhibitors

Recurrent glioblastoma patients with received anti-angiogenic treatment

T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging

3-Tesla conventional magnetic resonance imaging

Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy

Advanced imaging without contrast use

Cerebral blood volume and vessel architectural imaging parameters

Dynamic susceptibility contrast-weighted imaging

Ho Sung Kim, M.D.,Ph.D.

This study aims to evaluate whether pre-treatment MRI can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.

Although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. Allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment.

This is a prospective observational study and no active comparator will be used. Study participants include adult patients with recurrent glioblastoma.

We hypothesized that quantifying changes in multi-modal advanced MR imaging techniques would allow early treatment response and long-term prediction in glioblastomas.

Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

Prospective Observational Study of Imaging-based Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastomas

Data sharing if raw imaging data outside Korea is prohibited by Korean government. For anonymized imaging data, part of cases may be feasible on the approval of the principle investigator.

Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression.

Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month

Time from anti-angiogenic treatment to death

Ho Sung Kim

Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Capecitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Taxane

Antineoplastic Agents, Immunological

Growth Inhibitors

A Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22 + 1800 mg/m2 Capecitabine day 1-14 q22

A Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22

Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study

Taxane, Avastin

Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 + Capecitabine 1800 mg/m2 day 1-14 q22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study

Taxane, Avastin, Xeloda

Hans-Joachim Lück, Prof. Dr.

Kristina Lübbe, Dr.

The purpose of this study is to determine whether

* Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab.
* As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated.
* Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice.
* Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy.
* Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.
* Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.

Primary Objective:

- To determine the Progression Free Survival (PFS) in patients with metastatic breast cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).

Secondary Objective(s):

* To determine the objective response rate in both arms.
* To determine the duration of response in both arms.
* To determine the Time to Progression (TTP) in both arms.
* To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.
* To determine the overall survival rate 3 years after "Last Patient In".
* To determine PFS and TTP response rates in patient's ≥ age 65.
* To determine the toxicity and compliance in both arms.
* To determine the predictive value of serum markers such as VEGF.

A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma	NCT04143425	Adult Glioblast... Magnetic Resona... Bevacizimab	3-Tesla convent... Advanced imagin... Dynamic suscept...	18 Years - 80 Years	Asan Medical Center
A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer	NCT01200212	Breast Cancer	Taxane, Avastin Taxane, Avastin...	18 Years -	German Breast Group
Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma	NCT04143425	Adult Glioblast... Magnetic Resona... Bevacizimab	3-Tesla convent... Advanced imagin... Dynamic suscept...	18 Years - 80 Years	Asan Medical Center

Spots Global Cancer Trial Database for bevacizimab

Every month we try and update this database with for bevacizimab 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.

Spots Global Cancer Trial Database for bevacizimab

Every month we try and update this database with for bevacizimab 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.

Every month we try and update this database with for bevacizimab 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.