Intensity-modulated Radiotherapy Protocol in Cervix Cancer

Phase 2

• Conditions: Radiation
• Interventions: Radiation: High-dose Intensity-modulated radiotherapy

• Registration Number: NCT02993653
• Lead Sponsor: Seoul St. Mary's Hospital

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

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intensity-modulated radiotheapy arm	High-dose Intensity-modulated radiotherapy	Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival	30 months	Progression means locoregional recurrence, distant metastasis, and local tumor pregression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lee Jong Hoon; 🇰🇷 Suwon, Korea, Republic of