Intensity-modulated Radiotherapy Protocol in Cervix Cancer

Study Overview
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Brief Summary
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Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial

Detailed Description
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Radiotherapy 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 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

Official Title
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Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial

Conditions
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Radiation

Intervention / Treatment
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* Radiation: High-dose Intensity-modulated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 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 Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL Patients who have signed an approved informed consent and authorization Exclusion Criteria: Patients with recurrent cervical cancer Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node) Patients with distant organ metastasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensity-modulated radiotheapy arm<br>Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy | Radiation: High-dose Intensity-modulated radiotherapy<br>* Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression means locoregional recurrence, distant metastasis, and local tumor pregression | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 30 months | 
| Treatment-related adverse events are assessed by CTCAE v4.0. | Toxicity | acute within 3 months and chronic after 3 months after radiotherapy |