Oropharyngeal Cancer Clinical Trial
Official title:
Correlative Study of Nicotine Levels With Response Rates to Therapy Using Radiation Alone or in Combination With Chemotherapy in Head and Neck Cancer
Verified date | July 2021 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to evaluate the relationship between serum nicotine levels and tumor response of squamous cell cancers of the head and neck (SCCHN) to radiotherapy alone or in combination with chemotherapy. Correlation of RECIST response, volumatic response, pathologic response (in patients receiving post-treatment neck dissection), and hemodynamic response (tumor oxygenation and blood flow) will be performed.
Status | Completed |
Enrollment | 115 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A: Male or female aged 18 or older - B: Pathologically confirmed squamous cell carcinoma - C: Measurable disease using CT, MRI, or panendoscopy - D: Tumor sites to include: Oropharynx Hypopharynx Oral cavity Larynx Measurable disease with no evidence of primary - E: Patients to be treated with radiotherapy or chemoradiotherapy as a primary treatment modality. Patients to be treated with radiotherapy in combination with platinum based chemotherapy will be considered for enrollment. - F: Nutritional status to include patients that do not require placement of a feeding tube as well as patients that are feeding tube dependent. However, patients requiring total parenteral nutrition prior to initiation of treatment will be excluded. - G: ECOG performance status of 0, 1 or 2. - H: Standard of care chemotherapy inclusion criteria to include: i: No evidence of active angina pectoris or ventricular arrhythmia's; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.) ii: Absolute neutrophil count of > 1000/uL and platelet count > 100,000/uL iii: Serum total bilirubin < 1.5 mg/dL iv: Creatinine Clearance greater than 60 ml/min creatinine clearance to be calculated using the formula: (140 - age) x (wgt in kg) * (serum creatinine) x (72) * multiply by 0.85 for females v: If a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to treatment. Patients with grade II or greater neuropathy will be excluded from study. - I: Standard of care treatment will require counseling against the use of tobacco products and can include nicotine replacement at the request of the patient and discretion of treating physician. Patients who continue to use tobacco products as well as patients using any form of cessation strategy (nicotine replacement, bupropion, or other) will be eligible for enrollment. - J: Patients enrolled on experimental studies will be considered for enrollment with final selection to be made by Dr. Kudrimoti, Dr. Warren, Dr. Arnold, and Dr. Valentino. - K: Ability to give informed consent Exclusion Criteria: - A: Pregnant females. Males and females of childbearing potential must use effective contraception in order to prevent pregnancy during therapy. - B: Histology other than squamous cell carcinoma - C: Patients without measurable disease using CT, MRI, or panendoscopy - D: Patients eligible for surgical resection alone or with significant (> 25%) surgical tumor debulking prior to radiotherapy will not be considered for enrollment. Furthermore, patients who are otherwise not candidates for radiotherapy at the discretion of the treating physician will be excluded from enrollment. - E: Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible. - F: Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved. - G: Prior chemotherapy, prior irradiation or surgery for SCCHN will not be allowed. - H: Patients with metastatic disease will not be eligible for this study. - I: Patients with grade II or greater peripheral neuropathy will be excluded from study. - J: Patients receiving medication to prevent mucositis (palifermin, amifostine, or other). - K: Patients requiring total parenteral nutritional support prior to the initiation of treatment will not be eligible for study. |
Country | Name | City | State |
---|---|---|---|
United States | Markey Cancer Center | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Mahesh Kudrimoti |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of serum cotinine with volumetric response | RECIST criteria will be used as a correlate for standardization of tumor response. Volumetric analysis may provide better assessment of bulky tumor size that may have a large necrotic or hypoxic component that may be resistant to treatment. Furthermore, volumetric analysis has been associated with a higher rate of concordance to response based upon RECIST criteria. | 2 years from start of treatment | |
Secondary | Correlation of serum cotinine with toxicities during treatment. | Toxicities will be graded using the National Cancer Institute (NCI) scale for acute and subacute toxicity and the Radiation Therapy Oncology Group's late toxicity scale. | 90 days from start of treatment | |
Secondary | Correlation of serum cotinine with time to progression. | Time to progression will be calculated as the time interval between the start of radiation treatment and the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions | 2 years | |
Secondary | Correlation of serum cotinine with survival | Survival will be calculated from the start of radiation to the date of death. | 5 years from start of treatment | |
Secondary | Correlation of serum cotinine with response to treatment | Both pathologic and radiographic response to therapy will be assessed where possible. Primary tumors will be assessed by the attending otolaryngologist by panendoscopy, with biopsies taken in the case of a question of response. Nodal disease response will be assessed by radiographic means. All patients will be assessed for response at the end of primary treatment. | 5 years | |
Secondary | Investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy). | Previous studies indicated that there is a significant increase in blood flow in the early two weeks of radiation therapy and decreases in the following weeks, while the tissue oxygen saturation tends to decline continually | End of Treatment |
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