Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
The purpose of this study is to examine disease control of contemporary oropharyngeal cancer.
As for many other primary subsites of the head and neck district, two main options have been traditionally employed for the treatment of squamous cell carcinoma of the oropharynx (ORO-SCC), surgery and radiotherapy (RT). The latter has been shown to be less 'invasive' and morbid than radical surgery and therefore has gained consensus as first line option in ORO-SCC at many Institutions across the country.
Surveillance Epidemiology and End Results (SEER) data from 1975 to 2002 show an approximate 5% to 8% improvement in 5-year overall survival for squamous head and neck cancer. Most of this improvement occurred in oropharyngeal carcinoma. Table 1 summarizes results from contemporary series using non-surgical-based approach for ORO-SCC. They consistently show that long-term locoregional control rates are in the order of 80-95%.
Squamous Cell Carcinoma of Oropharynx
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase I/II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx|
- Grade 3+ late toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To achieve prevalence of grade 3+ late toxicity at 2 years < 15% while maintaining a locoregional tumor control > 85 + or - 7% at the same time interval (toxicity is scored at 5.11 and 9.5 and locoregional and locoregional control at 9.4).
- Quality of Life [ Time Frame: Pretreatment, 8 weeks, 3 months, then every 3 months fo rthe first 2 years, then every 6 months for years 3-5 and finally annually ] [ Designated as safety issue: No ]To determine the quality of life of surviving patients (5.11 and 9.5)
- Adverse events and their cause [ Time Frame: Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5 and finally annually ] [ Designated as safety issue: Yes ]To determine the nature and prevalence of side effects at different time intervals and describe their relationship to pretreatment function and local dose and treated volume.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Dose de-escalating radiation therapy with chemotherapy
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx receiving standard of care treatment based on clinical stage.
70 Gy, 63 Gy and 58.1 Gy to primary tumor and whole neck (PTV1-3) in 35 fractions. The Px to each PTV is reported in table 6. Now we have 4 dose levels, 70, 63, 58.1 and 50.75 Gy. In cases after primary tumor surgery where there is no residual macroscopic disease left, the total dose to PTV1 can be reduced from 70 Gy to 68.25 Gy. In this case PTV68.25 is treated as PTV70 regarding overlap with the various OAR's.Drug: Cisplatin
The first dose of cisplatin 40mg/m2 IV will be administered within the first 3 days of the start of RT and repeated weekly for the duration of RT. If RT is held, cisplatin will also be held.Drug: Carboplatin
6.2.4 Switch to Carboplatin: In case of any of the followings, cisplatin will be substituted to carboplatin: serum creatinine above the upper limit of normal and creatinine clearance < 60; refractory magnesium and electrolyte wasting; ototoxicity; peripheral neuropathy grade 2. Weekly carboplatin dosing would be at AUC = 2; q 3wk dosing at AUC = 5.
|Contact: Harry Quon, M.D.||email@example.com|
|Contact: Kelly Szajnafirstname.lastname@example.org|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator: Quon Harry, M.D.|
|Principal Investigator: Arlene Forastiere, M.D.|
|Sub-Investigator: Ralph Tufano, M.D.|
|Sub-Investigator: Christine Gourin, M.D.|
|Sub-Investigator: Jeremy Richmon, M.D.|
|Sub-Investigator: Wayne Koch, M.D.|
|Sub-Investigator: Nafi Aygun, M.D.|
|Sub-Investigator: William Westra, M.D.|
|Sub-Investigator: Heather Starmer, MA, CCC-SLP|
|Sub-Investigator: Kim Webster, MA,MS, CCC-SLP|
|Sub-Investigator: Donna Tippett, MPH,MA,CCC-SLP|
|Sub-Investigator: Todd McNutt, PhD|
|Sub-Investigator: Amanda Blackford, Sc.M.|
|Sub-Investigator: Mary Griffith, RN|
|Sub-Investigator: Shirl DiPasquale, RN|
|Sub-Investigator: Giuseppe Sanguineti, M.D.|
|Sub-Investigator: Nishant Agrawal, M.D.|
|Sub-Investigator: Christine Chung, M.D.|
|Sub-Investigator: Shanthi Marur, M.D.|
|Sub-Investigator: Moody Wharam, M.D.|
|Principal Investigator:||Quon Harry, M.D.||The Johns Hopkins University School of Medicine|
|Principal Investigator:||Arlene Forastiere, M.D.||The Johns Hopkins University School of Medicine|