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Secondary endpoints: details revised at 4 of 5 entries
Study description shortened, about 243 words
MinorStart date changed from estimate of Oct 2019 to Oct 10, 2019
Site contacts updated at 1 of 2 sites
v16
MinorStart date: Sep 2019 to Oct 2019v15
MinorStudy sites: 1 to 2v14
NotableStart date: Jul 2019 to Sep 2019
Study title shortened, about 2 words
v13
NotableStart date: May 2019 to Jul 2019v12
NotableStart date: Feb 2019 to May 2019v11
MinorStart date: Jan 2019 to Feb 2019v10
MinorStart date: Dec 2018 to Jan 2019v9
MinorStart date: Nov 2018 to Dec 2018v8
MinorStart date: Oct 2018 to Nov 2018v7
MinorStart date: Sep 2018 to Oct 2018v6
MinorStart date: Aug 2018 to Sep 2018v5
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Jul 2018 to Aug 2018
Site details revised
v4
NotableStart date: May 2018 to Jul 2018v3
MinorStudy title shortened, about 2 wordsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients.
Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.