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iluvmms's picture
iluvmms
Posts: 134
Joined: Aug 2009

I had my scan and follow up yesterday with the surgeon and radiation oncologist that di my Therashperes. Scan was good and CEA was only a .7, yeah!!! Now I get to go to 6 month scans.
I had a in depth conversation with rad onc about the theraspheres. They are totally different than the SIr Spheres. The Sir Spheres are and have been FDA approved for CC, and the Theraspheres are just about to start trials!!! I had no idea of this until yesterday, He is following my scans very closely and is even using them for his lectures. For those of you whome dont know my history, here it is: I was told I not a candidate for liver resection due to sive and location of liver tumors.

stage IV july 09
colon resection july 09
chemo til dec. 09
theraspheres 12/28/2009
liver resection April 10
chemo til sept 10
clean scans since

http://www.cxvascular.com/in-interventional-oncology/in-interventional-oncology/fda-approves-phase-iii-clinical-trial-to-evaluate-therasphere-for-liver-metastases-

Here is an article I found:

FDA approves phase III clinical trial to evaluate TheraSphere for liver metastases
Friday, 25 Mar 2011 16:08
Nordion announced on 23 March 2011 that it has received FDA approval to conduct a phase III clinical trial for TheraSphere under an Investigational Device Exemption (IDE) to evaluate the safety and effectiveness of its product in colorectal cancer patients whose disease has metastasised to the liver.

The EPOCH study, a randomised phase III clinical trial will include 30 sites worldwide, with a target enrolment of approximately 350 patients. The main objective of the trial is to examine a number of safety and efficacy endpoints in patients who have developed liver tumours from colorectal cancer and who have failed first-line chemotherapy. Participants in the treatment group will receive both TheraSphere and second-line chemotherapy, while patients in the control group will only receive the chemotherapy regimen.

“The goal is to investigate whether TheraSphere used in combination with chemotherapy can offer patient outcome advantages that are superior to those of chemotherapy alone,” explained Mary Mulcahy, Northwestern University, Chicago, USA, and principal investigator of the study.

According to the US National Cancer Institute, colorectal cancer is the third most common cancer in both men and women. An estimated 60% of colorectal cancer patients will eventually develop liver tumours and most deaths associated with colorectal cancer are due to inoperable liver tumours.

About TheraSphere

TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometres in diametre) containing radioactive yttrium-90 (Y-90).

TheraSphere has been cleared by the FDA under a Humanitarian Device Exemption. This type of approval is based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. TheraSphere, 100% reimbursed by Medicare and many commercial health insurers, is used to treat patients with unresectable hepatocellular carcinoma and can be used as a bridge to surgery or transplantation in these patients. It can also be used to treat primary liver cancer patients with portal vein thrombosis.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Some patients experience some loss of appetite and temporary changes in several blood tests.

AnneCan
Posts: 3692
Joined: Oct 2009

Congratulations on such wonderful results!

smokeyjoe
Posts: 1428
Joined: Feb 2011

Wow, you were a pioneer and didn't even realize it, congratulations on your results :)

jjaj133's picture
jjaj133
Posts: 869
Joined: Mar 2011

wonderful news! Congratulations!!!
Judy

janie1
Posts: 753
Joined: Apr 2011

That is great and very interesting. I'm still learning, many terms to learn. Does this apply to adenocarcinoma? The article said (with unresectable hepatocellular carcinoma). I'm assuming all carcinomas. Thanks for sharing great info.

pepebcn's picture
pepebcn
Posts: 6352
Joined: Aug 2010

Feel so happy for your success ! That's the news we like to to hear !
Hugs!

Lilmiss82's picture
Lilmiss82
Posts: 257
Joined: Dec 2009

.7 cea! Wow:) I'm so happy for you

Buzzard's picture
Buzzard
Posts: 3073
Joined: Aug 2008

Great news .enjoy every minute of it................buzz

herdizziness's picture
herdizziness
Posts: 3642
Joined: Apr 2010

What great news, Congrats!!!
Winter Marie

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