Radiation
Conditions
Brief summary
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
Detailed description
Radiotherapy 1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx 2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR) * Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks * Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week
Interventions
RADIATIONHigh-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix 2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 3. Patients with adequate bone marrow function: Absolute nutrophil 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/mL 5. Patients who have signed an approved informed consent and authorization
Exclusion criteria
1. Patients with recurrent cervical cancer 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 (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node) 4. Patients with distant organ metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 30 months | Progression means locoregional recurrence, distant metastasis, and local tumor pregression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 30 months | — |
| Treatment-related adverse events are assessed by CTCAE v4.0. | acute within 3 months and chronic after 3 months after radiotherapy | Toxicity |
Countries
South Korea
Contacts
Primary ContactJong Hoon Lee, MD
Outcome results
None listed