Prophylactic Irradiation of the Para-Aortic Lymph Nodes and Supraclavicular Lymph Nodes in Locally Advanced Uterine Cervical Cancer
Prophylactic Irradiation of the Para-Aortic Lymph Nodes and Supraclavicular Lymph Nodes in Locally Advanced Uterine Cervical Cancer
This study is an open-label, randomized study, which is designed to investigate the efficacy
 of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node
 (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally
 advanced uterine cervical cancer. This study includes a translational research component in
 that all the primary tumors and lymph node are stained with Sema4c, before randomization.
 According to the investigators study result, patients with more pelvic lymph node metastasis
 are more likely to develop distant metastasis including the recurrences at PAN and
 supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for
 expression of Sema4c just after registration, and before the patients are randomized to each
 arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with
 Sema4c-positive lymph node.
Inclusion Criteria:

 -  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

 -  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 with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of
 100, 90, 80, 70, 60, 50

 -  Age: 18≤age≤80

 Exclusion Criteria:

 -  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.