NCT02993653

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

3.4 years

First QC Date

December 11, 2016

Last Update Submit

December 14, 2016

Conditions

Radiation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

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

    30 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

Intensity-modulated radiotheapy arm

EXPERIMENTAL

Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy

Radiation: High-dose Intensity-modulated radiotherapy

Interventions

High-dose Intensity-modulated radiotherapyRADIATION

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

Intensity-modulated radiotheapy arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lee Jong Hoon

Suwon, South Korea

RECRUITING

Related Publications (2)

  • Kang HB, Kim SH, Lee JH, Lee HC, Kang NK, Lee JH. MRI-based volumetric tumor parameters before and during chemoradiation predict tumor recurrence and patient survival in locally advanced cervical cancer: a subgroup analysis of a phase II prospective trial. Int J Clin Oncol. 2024 May;29(5):620-628. doi: 10.1007/s10147-024-02490-7. Epub 2024 Mar 26.

    PMID: 38530569DERIVED

  • Lee HC, Jeong JW, Lee JH, Kim SH, Park DC, Yoon JH, Kim SI, Lee JH. High-dose (60 Gy) intensity-modulated radiotherapy with concurrent weekly cisplatin followed by intracavitary radiation in locally advanced cervical cancer: A phase II prospective clinical trial. Gynecol Oncol. 2023 Oct;177:142-149. doi: 10.1016/j.ygyno.2023.08.018. Epub 2023 Sep 7.

    PMID: 37689018DERIVED

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Jong Hoon Lee, MD

    St. Vincent's Hospital, South Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Hoon Lee, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 15, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 15, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)