High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies.
High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies.
This phase II study of high dose intensity modulated radiation therapy in the cervical cancer
 with metastatic lymphadenopathies at initial diagnosis
Lymph node (LN) involvement in cervical cancer is a poor prognostic factor(1). Although lymph
 node evaluation is not a part of the International Federation of Gynecology and Obstetrics
 (FIGO) staging system(2), it is generally performed as one of the initial workup of patients
 with cervical cancer by use of modern imaging tools for accurate evaluation of the disease
 extent and possible treatment adjustment. Kidd et al reported the positron emission
 tomography with [18F] fluorodeoxyglucose (FDG-PET)-positive lymph node rate is 47% at
 diagnosis in 560 patients. They also showed that within a stage, patients with PET-positive
 lymph nodes had significantly worse disease specific survival than those with PET-negative
 lymph nodes (p<0.001)(3).

 Historically, dose escalation to the pelvic or para-aortic metastatic lymphadenopathies was
 not given as much attention as primary uterine cervical lesion partly because of the expected
 increased risk of bowel toxicity with when conventional radiotherapy technique was used.
 Unlike for the head and neck cancer where intensity modulated radiation therapy (IMRT) or
 tomotherapy was actively used for treatment of large lymphadenopathies and shown to produce
 improved disease control(4, 5) , there are few similar studies for cervical cancer. It is
 well known that more than 60 Gy10 2Gy equivalent dose (EQD2, α/β=10 Gy) is needed to control
 the gross tumor sized of 10 mm, containing 109 cells, according to the logarithmic cell
 killing(6). Theoretically, pelvic and para-aortic LNs (PAN) could not be controlled with the
 dose of 45-50 Gy10 EQD2, and we need to escalate the dose as much as possible with new
 radiation technology.

 In the current is study, we evaluate the LNs control rate, toxicity rate, progression-free
 survival and overall survival in cervical cancer patients with lymphadenopathies and treated
 with high dose intensity modulated radiation therapy
Inclusion Criteria:

 1. 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])

 2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2

 3. 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.

 4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.

 5. Patients who have signed an approved informed consent and authorization

 Exclusion Criteria:

 1. Patients with recurrent LN(s) which was(were) previously irradiated.

 2. Patients who have diagnosis of other malignance tumors except papillary or follicular
 thyroid cancer or skin cancer

 3. Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g.
 supraclavicular or mediastinal metastatic lymphadenopathy)

 4. Patients with distant organ metastasis (e.g. bone, lung, brain…)