Intensity-modulated Radiotherapy Protocol in Cervix Cancer

Seoul St. Mary's Hospital80 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation

Interventions

High-dose Intensity-modulated radiotherapyRADIATION

Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lee Jong Hoon

Suwon, South Korea

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival

Progression means locoregional recurrence, distant metastasis, and local tumor pregression

Time frame: 30 months

Secondary Outcomes

Overall survival

Time frame: 30 months

Treatment-related adverse events are assessed by CTCAE v4.0.

Toxicity

Time frame: acute within 3 months and chronic after 3 months after radiotherapy

Central Contacts

Jong Hoon Lee, MD

CONTACT

+82-010-8607-1269 koppul@catholic.ac.kr

Data from ClinicalTrials.gov

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