This phase II study of high dose intensity modulated radiation therapy in the cervical cancer
with metastatic lymphadenopathies at initial diagnosis
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Full eligibility criteria for NCT01730651
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed carcinoma of the uterine cervix (including clear cell and small cell carcinoma), with metastatic lymphadenopathies (any of pelvis or PAN >1.5 cm in short diameter, with/without biopsy proven inguinal lymph node [ING])
Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2
Patients with adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning.
Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.
Patients who have signed an approved informed consent and authorization
Patients with recurrent LN(s) which was(were) previously irradiated.
Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g. supraclavicular or mediastinal metastatic lymphadenopathy)
Patients with distant organ metastasis (e.g. bone, lung, brain…)
Tris trial is registered with FDA with number: NCT01730651. The sponsor of the trial is National Cancer Center, Korea and it is looking for 55 volunteers for the current phase.
Official trial title: A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis.
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