RadiationPhase 2NCT02993653
Intensity-modulated Radiotherapy Protocol in Cervix Cancer
A Phase 2 study testing High-dose Intensity-modulated radiotherapy in people with Radiation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation
- What is being tested?
- High-dose Intensity-modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Lee Jong Hoon
Suwon
Jong Hoon Lee, koppul@catholic.ac.kr
About this study
Official title: Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
Read the detailed description
Radiotherapy
- 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
- 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
- Conditions
- Radiation
- Being tested
- High-dose Intensity-modulated radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose Intensity-modulated radiotherapyRadiation
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intensity-modulated radiotheapy arm | Experimental | Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy Receives: Radiation: High-dose Intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression means locoregional recurrence, distant metastasis, and local tumor pregression
Measured: 30 months
Secondary outcomes (2)
Overall survival
Measured: 30 months
Treatment-related adverse events are assessed by CTCAE v4.0.
Toxicity
Measured: acute within 3 months and chronic after 3 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hoon Lee, Seoul St. Mary's Hospital
- Investigators
- Jong Hoon Lee, MD, Principal investigator, St. Vincent's Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993653
- Sponsor's protocol ID
- VINPI1501
- Status last verified
- Dec 2016
- First submitted
- 11 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38530569Lee 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.
PubMed 37689018
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT02993653
- Acronym / sponsor ID
- VINPI1501
- Conditions
- Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensity-modulated radiotheapy arm | Experimental | Radiation: High-dose Intensity-modulated radiotherapyIntensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose Intensity-modulated radiotherapyPelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy | Radiation | Intensity-modulated radiotheapy arm |
Primary outcome
Progression-free survival
Time frame: 30 months
Progression means locoregional recurrence, distant metastasis, and local tumor pregression
2 secondary outcomes
Overall survival
Time frame: 30 months
Treatment-related adverse events are assessed by CTCAE v4.0.
Time frame: acute within 3 months and chronic after 3 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Derived from this study: PubMed 38530569Kang 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.
- Derived from this study: PubMed 37689018Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Hoon Lee, MD principal investigator
St. Vincent's Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-dose Intensity-modulated radiotherapy in people with Radiation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Hoon Lee, MD (+82-010-8607-1269, koppul@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993653, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.