Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03894891|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Nivolumab Drug: Cisplatin Drug: Docetaxel Radiation: Radioimmunotherapy||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug or combination of interventions is being studied.
Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or advanced head and neck cancer (head and neck cancer that has come back or is incurable) but is considered investigational for head and neck cancer patients who have not received prior chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sequential Therapy With Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer|
|Actual Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2024|
Docetaxel will be administered per standard institutional every 3 weeks Nivolumab will be administered intravenously every 3 weeks Cisplatin will be administered intravenously every 3 weeks Radioimmunotherapy will be conducted 3 weeks after the last cycle of TPN (docetaxel, cisplatin and nivolumab)
Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer
Other Name: OPDIVO®
Cisplatin is a chemotherapy medication used to treat a number of cancers
Other Name: Platinol
Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck
Other Name: Taxotere
Radiation Therapy to shrink or kill tumors.
Other Name: RT
- Laryngectomy-free survival [ Time Frame: 2 years ]To improve efficacy with respect to laryngectomy-free survival (LFS) at 2-years from time of study registration as the primary endpoint.
- Quality of life Measure, QLQ-C30 [ Time Frame: 2 years ]General "Quality of Life" or QOL will be assessed via a self-reported questionnaire at the timepoints outlined in the Study Calendar. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) contains 30 questions belonging to five functional scales, nine symptom scales, financial difficulty, and one global health status (quality of life) scale. The responses are graded on a scale of 1 to 4, where 1 is "not at all" and 4 is "very much".
- Quality of life Measure, QLQ-H&N35 [ Time Frame: 2 years ]"Quality of Life" or QOL specifically related to head and neck cancer will be assessed via a self-reported questionnaire at the timepoints outlined in the Study Calendar. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-H&N35) will be used to evaluate the reliability and validity of a new, disease-specific quality of life measure for patients with head and neck cancer: This questionnaire contains 35 questions with responses on a scale of 1 to 4, where 1 is "not at all" and 4 is "very much".
- Overall Survival [ Time Frame: 2 years ]Overall Survival (OS) is defined as the time from study registration to death due to any cause, otherwise, participants are censored at date last known alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894891
|Contact: Robert Haddad, MDemail@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Robert Haddad, MD 617-632-5260 firstname.lastname@example.org|
|Principal Investigator:||Robert Haddad, MD||Dana-Farber Cancer Institute|