Status:
UNKNOWN
Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aorti...
Detailed Description
Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix are included in this study. Absence of metastatic para-aortic lymphadenopathy is the prerequisite of the enro...
Eligibility Criteria
Inclusion
- Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB with only unilateral pelvic wall extension, and IVA
- Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
- Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
- Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
- Patients who have signed an approved informed consent and authorization
- Patients who have met the pre-entry requirements specified in section 6.0.
- Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
- Age: 18≤age≤80
Exclusion
- Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
- Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
- Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non- malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.
Key Trial Info
Start Date :
July 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00980759
Start Date
July 28 2006
End Date
December 31 2024
Last Update
September 8 2021
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769