Randomized phase III clinical trial of adjuvant radiation versus chemo-radiation in intermediate risk, stage I/IIa cervical cancer treated with initial radical hysterectomy and pelvic lymphadenectomy

Asan Medical Center0 个研究点目标入组 360 人开始时间: 待定最近更新: 2019年6月17日

适应症

试验速览

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•Eligible Patients
•1.Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy.
•2 Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
•2.1 Positive capillary-lymphovascular space involvement and one of the following:
•Deep third penetration
•Middle third penetration, clinical tumor = 2 cm
•Superficial third penetration, clinical tumor = 5 cm
•2.2 Negative capillary-lymphatic space involvement:
•Middle or deep third penetration, clinical tumor = 4
•3. Patients must have adequate:
•3.1 Hematologic function: ANC(absolute neutrophil count) = 1,500/mcl, platelets = 100,000/mcl
•3.2 Renal function: creatinine = UNL(upper normal limit) or calculated creatinine clearance = 60 mL/min
•3.3 Hepatic function: bilirubin = 1.5 x normal, alkaline phosphate and serum aspartate aminotransferase(SGOT) = 3 x normal
•3.4 patient with performance status 0, 1, 2.
•3.5 Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery.
•3.6 Patients who have met the pre-entry requirements
•3.7 Patients must have signed an approved informed consent and authorization permitting release of personal health information.
•3.8 Patients must be = 18 years of age.

•1.Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins.
•2. Patients with septicemia or severe infection.
•3. Patients with intestinal obstruction or gastrointestinal bleeding.
•4 Patients with postoperative fistula.
•5 Patients with cervix cancer who have received any previous radiation or chemotherapy.
•6 Patients whose circumstances do not permit completion of the study or the required follow-up.
•7 Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc).
•8 Patients with Performance Status of 3 or 4.
•9 Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol

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