JHU ICTR
Johns Hopkins Clinical Research Study

A Phase II Study of Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx
ClinicalTrials.gov

IRB Number: NA_00026771
Principal Investigator: Quon, Harry

Study Description:

This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with Squamous Cell Carcinoma of the Oropharynx. 
 
The study will look at giving a slightly smaller dose of radiation (de-Intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin). The possible surgery and or chemotherapy will be up to the participant’s doctor. 
 
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.
 
People with a certain type of head and neck cancer (oropharynx) may join. 
 
How many people will be in this study?
There will be about 60 people taking part in this study.
 

 



Eligibility Criteria:

Eligibility Criteria 

All the followings:
* Biopsy-proven SCC of the oropharynx (tonsil, base of tongue, pharyngeal wall or palate),
* Tumor positive for infection with human papillomavirus (HPV) virus (any subtype) as per JH Pathology assessment 
* Negative pregnancy test for women of childbearing potential
* T stage: 1, 2, 3. Surgery of the primary tumor is limited to incisional or excisional biopsies (i.e. tonsillectomy) even without macroscopic disease left. Positive resection margins and/or gross residual disease at the primary site are allowed; evaluation of primary tumor extent may require the use of a flexible fibroscope if deemed clinically necessary by the treating physician;  
- any N stage but resectable; lymph nodes in both sides of the neck are at risk of metastatic disease, according to clinical judgment, and require irradiation; pre-treatment surgery in the neck in the forms of incisional/excisional biopsy or a multilevel neck dissection is allowed only if there is gross tumor left at the primary site;
* No other malignancy except for non-melomatous skin cancer, early stage prostate  cancer (T<2a and PSA<10 and GLS<7) or a carcinoma not of head and neck origin disease free for > 5 yrs.                            
* - ANC > or = to 1000 /mm3
- Platelets >100,000/ mm3
    - Adequate hepatic function with bilirubin < 1.5 mg/dl
    - AST < 2x the upper limit of normal
    - ALT < 2x the upper limit of normal           
- estimated CCL > 60 cc/min -  Normal serum calcium (or normal corrected serum calcium)
* Cannot have distant metastasis (M0);
* ECOG performance status 0-1
* Patient’s nutritional and general physical condition must be considered compatible with the proposed radiotherapeutic treatment (cannot have unintentional and/or surgically unrelated weight loss > 20% in the preceding 3 months). *This assessment is a standard of care assessment for this patient population. This requirement can be waived by the investigator if the subject has an identifiable procedure which is the immediate and sole cause for the weight loss without an underlying pathological cause. An example of a situation like this would be if a participant is found to need a tonsillectomy during the pretreatment evaluations. It’s obvious that this scenario would be a non-pathological reason for such a weight loss. The PI will only have this ability to waive this criterion if and only if he can substantiate and document that the weight loss does not have a * Patient is judged to be mentally reliable to follow instructions and to keep appointments. (Please note that mental reliability is not determined through any specific test rather it is ascertained by the treating physician through conversation at the time of consult)
* No concurrent enrollment in another therapeutic protocol for the same diagnosis;
* Signed study-specific informed consent prior to registration. 
* Subject must understand that while they are on study they cannot have any concurrent curative therapy for their cancer other than what is outlined in the protocol.
 
Ineligibility Criteria
 
* Evidence of distant metastases.
* Absence of macroscopic disease after upfront surgery
* Previous irradiation for head and neck tumor; concurrent chemotherapy other than the treatment per protocol; previous chemotherapy ≤ 3 months from start of RT. 
* Active untreated infection. 
* Major medical or psychiatric illness, which in the investigators’ opinion would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy. 
* Use of amifostine or pilocarpine before and during radiotherapy is not allowed. 
*  Serum creatinine >1.3 or ULN, CCL < 60 cc/min, Peripheral neuropathy > grade 1,and/or frequency hearing loss that interferes with activities of daily living are contraindications to cisplatin but not to carboplatin 
 


Recruitment Contact Name:Kelly Szajna, RN
Contact Phone:410-614-3950
Contact E-Mail: kszajna1@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Hospital East Baltimore Campus

Study will provide compensation: No



Keywords:

  • Oropharynx
  • Carcinoma
  • Radiation