Stock DZ
20.04.2018 kl 13:17
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link to see how PCI GGK randomized study was designed earlier.

click on trial design and go to bottom for part-2

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-photochemical-internalisation-pci-for-advanced-bile-duct-cancer#undefined

"the second part of the trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in, but you will know which treatment you are due to have.

One group have photochemical internalisation (PCI) and combination chemotherapy
The other group have combination chemotherapy alone (this is the control group Open a glossary item)
Diagram for trial
For every 7 patients entered into the trial, 5 people have PCI and chemotherapy and 2 people have chemotherapy alone.

If you have PCI, you have the best dose of Amphinex, gemcitaibine and laser light treatment found in the first part of the trial. You have PCI in the same way as people in part 1. You stay in hospital for about the same amount of time and have the same tests as in part 1. You start combination chemotherapy about 3 weeks after your PCI treatment.

If you have chemotherapy alone, you start this within 3 weeks of joining the trial. You may have a stent put into your bile duct if your doctor thinks you need one.

Both groups have combination chemotherapy as described in part 1."

also if you look at the sponsors, you find both:
- Theradex
- Quanticate

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