Intensity-modulated Radiotherapy Protocol in Cervix Cancer

Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02993653
• Other study ID #: VINPI1501
• Status: Recruiting
• Phase: Phase 2
• First received: December 11, 2016
• Last updated: December 14, 2016
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: December 2016
• Source: Seoul St. Mary's Hospital
• Contact: Jong Hoon Lee, MD
• Phone: +82-010-8607-1269
• Email: koppul[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiation

Intervention

Radiation:
• High-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	Lee Jong Hoon	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression means locoregional recurrence, distant metastasis, and local tumor pregression	30 months	Yes
Secondary	Overall survival		30 months	Yes
Secondary	Treatment-related adverse events are assessed by CTCAE v4.0.	Toxicity	acute within 3 months and chronic after 3 months after radiotherapy	Yes