The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Chemotherapy + 80 cGy of RT
Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Primary Site Complete Response Rate
Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.
Time frame: Up to 50 days
Overall Response Rate
To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): \> 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 50 days
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
Quality of Life (QOL) will be measured pre- and post-treatment using a single 5-question QOL well-being survey. The change in score will be presented independently for each subpart of the QOL survey. 1. Physical; scores range from 7-35; higher scores indicate increased well-being 2. Social/family; scores range from 7-35; higher scores indicate increased well-being 3. Emotional; scores range from 6-30; higher scores indicate increased well-being 4. Functional; scores range from 7-35; higher scores indicate increased well-being 5. Additional Concerns; scores range from 10-50; lower scores indicate increased well-being 6. FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being 7. FACT-H\&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being 8. Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 50 days (pre- and post-treatment)
3-year Overall Survival
3-year overall survival
Time frame: From date of randomization until date of death from any cause, assessed up to 3 years