Hi lynney

It is not true that you cannot take yourself off treatment in a trial.

You can. You just withdraw your consent. They don't like it if you do as it mucks up their trial results if too many people do it. However, the researchers (well, statisticians actually) will have factored this into their calculations.

It is unethical and illegal to continue a patient on a trial when they do not want to be on it. A doctor is also likely to withdraw you if they feel it is not working - regardless of the protocol.

What you CAN'T do is choose which treatment you are allocated to.

Lastly, there is no evidence that Erbitux (cetuximab) works less well in HPV related tumours than other oral cancers. That is why this trial is so important. In addition to its primary purpose to compare the effects of cisplatin vs cetuximab, they will also be looking at any differences on HPV+ve tumours.

The landmark trial that got cetuximab registered for use in head and neck cancer was a trial by Bonner et al. In this trial they did not differentiate between HPV and non-HPV tumours but there were a lot of oropharyngeal cancers in the group which have a tendency to be HPV+ve (50-70% depending on which study you read). The researchers DID stratify by tumour site and the oropharyngeal tumour group did particularly well.



Karen
Love of Life to Alex T4N2M0 SCC Tonsil, BOT, R lymph nodes
Dx March 2010 51yrs. Unresectable. HPV+ve
Tx Chemo x 3+1 cycles(cisplatin,docetaxel,5FU)- complete May 31
Chemoradiation (IMRTx35 + weekly cisplatin)
Finish Aug 27
Return to work 2 years on
3 years out Aug 27 2013 NED smile
Still underweight