1

(5 replies, posted in Introductions!)

Aussie...welcome.  I echo the above comments and thought to include a link to archived postings containing the word: Australia.  Hope it is of help to you.
Hugs,
Marion

2

(7 replies, posted in Hospitals)

Daisy....we had some contact with Florida Hospital, Tampa.  I believe they have a group of physicians focused on biliary cancer.
Hugs,
Marion

You are most welcome, dear Gavin.

In regards to effectiveness (efficacy)  shown early in the study  phase II or Phase III  the sponsor (pharmaceutical company) is eligible to request " Breakthrough" designation. 
This accelerated approval request must be accompanied by "preliminary" evidence indicating that the drug  demonstrated substantial improvement over existing therapies 
FDA approval then assures quick application of drug to general patient population.   

What are clinically significant endpoints?
1.  Response to drug - usually the primary endpoint in phase II trials

CR (Complete Response)  = no "detectable" tumor is evident (also called "NED" - no evidence of disease -)  Potentially the treatment was curative.
Note:  Although there is no evidence of tumor(s) patient may not be cured.  CT or other scans have limitations in that it residual tumor may be too small to be visible.

Partial Response to drug (PR) - at least a 50% decrease in the total tumor volume. 

With evidence of some residual disease, a partial response is not curative because: a significant amount of tumor remains. 
Note:  some patients show evidence of remaining tumor however; they may achieve a complete response with continued treatment.  Also visible, residual "tumor"  may relate to  "dead" tumor or "scar" tissue. 

In adjuvant  setting (following "potentially curative surgery)
Disease Free Survival or Progression Free Survival:  generally used as endpoints In Phase III,  randomized trials (people chosen at random):

Progression Free Survival:  patient is alive and free of any significant cancer increase
Disease Free Survival is connected to Progression Free Survival and is used as endpoint of adjuvant therapy, clinical research study (trial) i.e. measure of recurrence of disease following surgery to remove all visible cancer.   These types of trials need comparisons i.e. randomization.

Hugs
Marion

Julie....happy to know I was of help to you.
Hugs
Marion

6

(149 replies, posted in Introductions!)

Oh, Matt.....unfortunately patients suffer from mistakes of medical personnel ....but you really had your share of, as they say "discomfort" and you rightly proclaim as  painful.
I hope that others chime in on the port issue, but I recall my husband mentioning slight discomfort for one week following the procedure.
Prior to accessing the port for infusion  his nurse placed a warm wash rag over the area - it helped as well.
Hugs,
Marion

His letter to the NCI Community:
http://www.cancer.gov/aboutnci/director … esignation

http://www.nih.gov/news/health/mar2015/nih-04.htm

Sean...please see my response in your second posting on this site.
Hugs,
Marion

Sean....a warm welcome from me as well.  Princess Margaret Hospital (Toronto) treats many Cholangiocarcinoma patients as well as conducts or participates in clinical research studies.  I would advise you to contact their biliary oncologist as well as the radiologist. 
Stay strong...you are doing everything right.  Second opinions  are considered standard at this time.  Please keep us posted.
Hugs,
Marion

Note:  what is a domino transplant?  See below link for explanation:
http://www.mayoclinic.org/departments-c … rch/domino

July....this is a rather simplified explanation.  There are academic research studies -  generally peer reviewed for accuracy and then published - and then there are clinical research studies i.e. clinical trial studies.  The academic research studies (most often) require clinical research studies to validate the accuracy in a large patient population and in a clinical setting (clinical research studies.) 
Clinical research studies come in phases:
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
•Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

•Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 

If effectiveness (efficacy) is shown early in the study (either phase II or Phase III) then the FDA will release the drug quickly to the general patient population.  In most instances though, the study will have to be conducted in the time set. 

The last and forever ongoing •Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Several academic studies have shown for adjuvant therapy to be effective.  And, that may very well be true....but we won't know for sure unless a large scale phase III clinical research study provides the data we are looking for. 

Why is Germany conducting this study?  No answer other than they were able to pull it off whereas other countries did not.

Hugs,
Marion

Julie....I too am disappointed with the quality of the video. 

To answer your question: unfortunately no - we will not be able to receive any data prior to the projected date.   For diseases such as our,  patient accrual takes time.  Some drop out (for various reasons) and new patients enter the clinical research study.  This particular study aims at recruiting 440 resected gallbladder and CCA patients; quite difficult in itself.  Considering the treatment time followed by the collection and analysis of data, one can understand the extensive, projected time frame. 

Hugs,
Marion

14

(149 replies, posted in Introductions!)

Matt.......you have reason to complain; don't hold back.  As far as I know, antiemetics  will be administered each time however; it can be adjusted according to individual response.
Hugs,
Marion

A select few presenting with hilar (perihilar) or even intrahepatic disease may be eligible for liver transplantation. 

Please take a look at our home page:
http://cholangiocarcinoma.org/the-disea … t-options/

16

(17 replies, posted in Introductions!)

Stevie....good luck with your visit and please mention your pain issues.  There is plenty of prescription medication available. 
Hugs,
Marion

Thanks much, Colleen.
Hugs,
Marion

Thanks, Gavin. 
This presentation encompassed many important issues - it's worth the watch - I will try to answer questions you may have.

We are awaiting the data from several clinical trials which may potentially  change  treatments of Cholangiocarcinoma patients.

Although the majority of physicians recommend adjuvant (post resection) chemotherapy, the outcome of the (3)  below mentioned clinical research studies will prove/disprove the validity of this approach.     

UK:  https://clinicaltrials.gov/ct2/show/NCT00363584
Do extrahepatic (hilar and distal)  resected CCA patients benefit from adjuvant therapy with Capecitabine (Xeloda?

France:  https://clinicaltrials.gov/ct2/show/NCT01313377
Do extrahepatic (hilar and distal) resected CCA patients benefit from adjuvant GEMOX treatment?

Germany:  https://clinicaltrials.gov/ct2/show/NCT02170090
Do CCA (intrahepatic, hilar, distal) resected patients benefit from adjuvant GEM/CIS treatment?

The below study is comparing progression free survival of extrahepatic (hilar, distal) CCA with advanced or metastatic disease, who have been treated with Gem/Cis as first line of treatment but now have  progressed. 
Korea:  https://clinicaltrials.gov/ct2/show/NCT01470443
Is XELOX as effective as GEMOX?

The ABC-6 study
UK:  https://clinicaltrials.gov/ct2/show/NCT01926236
CCA patients (intrahepatic, distal, hilar)  non metastatic, but locally advanced, who are fully active, able to carry on all pre-disease performance without restriction or may be restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.  One arm (group) of participants will receive monthly clinical review and active symptom control as needed, including biliary drainage, antibiotics, analgesia, steroids, anti-emetics, other palliative treatment for symptom control, palliative radiotherapy, blood transfusion.
The other control group will receive FOLFOX.

USA https://clinicaltrials.gov/ct2/show/NCT02200042
Intrahepatic, non-resectable, localized progressed (non-metastatic) CCA patients are divided in 2 groups:
Group A:  will receive Gem/Cis 
Group B:  will receive Gem/Cis plus radiation.  With or Without Radiation Therapy in Treating Patients With Localized Liver Cancer That Cannot Be Removed By Surgery

Hugs,
Marion

Connie.....this never could have happened without you.  A big thank you right back at you.
Hugs,
Marion

20

(3 replies, posted in General Discussion)

You may also want to take a look at the surgery link on our site:
http://cholangiocarcinoma.org/the-disea … t-options/

You are the best, Gavin. 
Marion

We encourage everyone to participate in this important secure data base.  See what it can do for you?
http://cholangiocarcinoma.org/wp-conten … raphic.pdf

In order to better serve our global patient/caregiver community we continuously update the information on our website. 
Please take a moment (or more) and familiarize yourself with the numerous resources available to you:

The Cholangiocarcinoma Foundation website
http://cholangiocarcinoma.org/

Board of Directors:
http://cholangiocarcinoma.org/the-chola … directors/

Medical Advisory Board: http://cholangiocarcinoma.org/the-chola … ry-boards/

Nursing Advisory Board:
http://cholangiocarcinoma.org/the-chola … ory-board/

The disease of Cholangiocarcinoma
Overview: http://cholangiocarcinoma.org/the-disease/defined/

Symptoms: http://cholangiocarcinoma.org/symptoms/

Staging:   http://cholangiocarcinoma.org/the-disease/staging/

Treatment Options:  http://cholangiocarcinoma.org/the-disea … t-options/

Risk Factors:  http://cholangiocarcinoma.org/risk-factors/

Key Statistics: http://cholangiocarcinoma.org/key-statistics/

Newly Diagnosed:  http://cholangiocarcinoma.org/newly-dx/

Biliary Information Emergency Card: http://cholangiocarcinoma.org/biliary-e … tion-card/

Caregivers: http://cholangiocarcinoma.org/caregivers/

Patient Registry: http://cholangiocarcinoma.org/professio … -registry/

Further Medical Research: http://cholangiocarcinoma.org/professio … nic-study/

Clinical Trials Now Enrolling: http://cholangiocarcinoma.org/professio … al-trials/

Major Cancer Centers:  http://cholangiocarcinoma.org/for-patie … r-centers/

Educational Material:  http://cholangiocarcinoma.org/professio … materials/

Glossary:  http://cholangiocarcinoma.org/the-disease/glossary-2/

Resources:  http://cholangiocarcinoma.org/for-patients/resources/

Webinar:  http://cholangiocarcinoma.org/videos/

CCF Fall Newsletter:  http://cholangiocarcinoma.org/misc/2014 … ewsletter/

And much, much.   http://cholangiocarcinoma.org/

Hugs,
Marion

http://www.dana-farber.org/Newsroom/New … ments.aspx

Judy....I too wish for someone else to chime in on your question.
Hugs,
Marion