Quarterback 2 - Sequential Therapy With Reduced Dose Chemoradiotherapy for HPV Oropharynx 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: NCT02945631|
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced HPV Positive Oropharynx Cancer||Radiation: PTV56 Radiation: PTV50.4||Not Applicable|
In general, patients with Human Papilloma Virus Oropharynx Cancer (HPVOPC) are young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from radiotherapy. While the long-term consequences of chemotherapy for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients. Identifying appropriate endpoints and study arms which will allow an early assessment of outcomes will be problematic, particularly for equivalence studies wherein survival differences are small, and where prolonged time periods and large patient numbers are necessary to accurately assess outcomes. For Sequential Therapy as given with TAX 324, 3-year PFS may be an appropriate endpoint. The same may not be possible for CRT. The best example of changing outcomes in CRT trials would be R91-11, in which a premature negative conclusion regarding the efficacy of induction therapy was published with the early analysis. Late toxicity and morbidity, a hallmark of upfront cisplatin-based CRT trials, led to equivalence between induction therapy and CRT for laryngectomy-free survival at 5 years, and more importantly a non-significant relative 10% improvement in overall survival in the PF induction arm compared to the CRT arm which included an every 3-week bolus cisplatin for 3 cycles during radiotherapy.
The survival results in HPVOPC achieved in TAX 324 and preliminary data from ECOG 1308 strongly suggest that it might be possible to reduce long-term morbidity in HPVOPC and preserve survival perhaps by better patient selection and by reducing radiotherapy intensity in the context of ST for more advanced cases. Best approach of HPV-negative disease might be with novel therapies and more aggressive Sequential Therapy (ST) or CRT.
Current radiation dose reduction trials are under way in ECOG, RTOG and other radiation based groups. The data from TAX 324 suggest that it is possible to reduce the radiation dose because of the superior progression free survival and the ability to select risk based CRT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quarterback 2: A Phase II Clinical Trial of Sequential Therapy and De-Intensified Chemoradiotherapy for Locally Advanced HPV Positive Oropharynx Cancer|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Experimental: Reduced Dose Radiation
All patients will receive daily radiation treatment with intensity-modulated radiotherapy (IMRT) - PTV56 and PTV50.4. Treatment will be given 5 days per week and will not routinely be delivered on Saturday, Sunday or major holidays unless a treatment is missed during the week due to technical and/or medical reasons. No more than 5 treatments should be given per week.
total dose of 56 Gy in 2.0 Gy/fraction x 28 fractions.
total dose of 50.4 Gy in 1.8 Gy /fraction x 28 fractions.
- Progression Free Survival (PFS) [ Time Frame: 3 years ]The comparative rate of progression free survival
- Progression Free Survival [ Time Frame: 5 years ]The comparative rate of progression free survival
- Local-regional control (LRC) [ Time Frame: 3 years ]The comparative rate of local-regional control
- Local-regional control (LRC) [ Time Frame: 5 years ]The comparative rate of local-regional control
- Overall Survival (OS) [ Time Frame: 3 years ]
- Overall Survival (OS) [ Time Frame: 5 years ]
- Acute Toxicity [ Time Frame: 5 years ]Rate of acute toxicity
- Long Term Toxicity [ Time Frame: 5 years ]Rate of long term toxicity
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): NCT02945631
|Contact: Marshall Posner, MDemail@example.com|
|Contact: Elizabeth Royfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Marshall Posner, MD|
|Principal Investigator:||Marshall Posner, MD||Icahn School of Medicine at Mount Sinai|