Phase II study to evaluate toxicity and clinical outcomes of definitive Helical Tomotherapy for primarily unresected carcinoma cervix using Fluoro-deoxy glucose Positron Emission Tomography based radiotherapy planning [PET Study]â??

Department of Biotechnology Government of India0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•3.1 Conditions for patient eligibility
•3.1.1 Pathologically proven diagnosis of cervical cancer within 90 days of registration
•3.1.2 Appropriate stage for protocol entry, including no ineligible node criteria or distant metastases, based upon the following minimum diagnostic workup:
•History/physical examination within 45 days prior to registration
•Patient is between 18 â?? 65 years
•Chest X Ray, MRI pelvis and whole body PET-CT should be performed for initial radiological staging.
•ECOG Performance Status 0-2
•CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
•Absolute neutrophil count (ANC) >= 1,500 cells/mm3
•Platelets >= 100,000 cells/mm3
•Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >=
•10.0 g/dl is acceptable.)
•For patients receiving chemotherapy:
•Cisplatin will be used concurrent with radiation therapy to a dose of 40 mg/m2 to a maximum dose of 70 mg weekly for 5 such cycles.
•Within 14 days prior to registration, serum creatinine <= 1.0 mg/dL and calculated creatinine clearance >= 50 cc/min. Both tests must be within these limits.
•The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section)
•AST <= 2 x ULN
•Bilirubin <= 2 x ULN
•Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded
•Patients must provide study specific informed consent prior to study entry.

•Patients who exceed the weight/size limit of the treatment table or CT scanner, mental status Changes or bladder control problems that make the patient unable to comply with bladder-filling instructions, patients with distant metastases, nodes within 2 cm of the midline in the span of the uterus and /or para aortic lymph node disease above the level of aortic bifurcation, nodes > 3 cm
•Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
•Transmural myocardial infarction within the last 6 months
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•Other major medical illness which requires hospitalization
•Hepatic insufficiency
•Patients with prior treatment with platinum-based chemotherapy
•Poorly controlled diabetes

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