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Clinical Trials/NCT02993653
NCT02993653UnknownPhase 2

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

Seoul St. Mary's Hospital1 site in 1 country80 target enrollmentStarted: January 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
80
Locations
1
Primary Endpoint
Progression-free survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: 30 months

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jong Hoon Lee

Professor

Seoul St. Mary's Hospital

Study Sites (1)

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