Recurrent Ovarian CancerPhase 2NCT03618706
Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
A Phase 2 study testing Involved-field radiotherapy in people with Recurrent Ovarian Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- Involved-field radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2018to 9 May 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed ovarian carcinoma
- Patients who received "standard treatment" for each stage as a primary treatment
- No. of recurrent lesions:
- If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2
- Size of recurrent lesions ≤5 cm
- All recurrent lesions are available for involved-field radiotherapy
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- Within 60 days before enrollment:
- Absolute neutrophil count ANC ≥ 500 / mm3
- Platelet ≥ 50,000 / mm3
- Hb ≥ 8.0 g / dl
- Good performance status (ECOG 0-1)
Who cannot join
- Brain metastasis
- Diffuse peritoneal carcinomatosis
- Malignant pleural effusion
- History of previous salvage radiotherapy for recurrent lesions
- History of other malignancy or severe/unstable medical condition
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Korea, 120-752
YongBae Kim, MD, 82-10-6256-2592, ybkim3@yuhs.ac
About this study
Official title: A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- Involved-field radiotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Involved-field radiotherapyRadiation
After the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| involved-field RT + standard salvage treatment | Experimental | Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer Receives: Radiation: Involved-field radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS)
Measured: 2 years after radiotherapy
Secondary outcomes (4)
Local control of recurred lesions
Measured: 2 years after radiotherapy
Any other new recurrence events
Measured: 2 years after radiotherapy
Radiotherapy-related complications
Measured: 2 years after radiotherapy
Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)
It means the interval between the last date performing the previous chemotherapy (before the start of involved-field radiotherapy) and the first date performing the new regimen of chemotherapy (for the disease failures after the involve-field radiotherapy). We want to measure this interval because we want to check the capability of involved-field radiotherapy to delay the need for the new regimen of chemotherapy for the progressive diseases.
Measured: 2 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start10 May 2018
- Primary completion9 May 2023 (estimated)
- Study completion9 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618706
- Sponsor's protocol ID
- 4-2018-0299
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03618706
- Acronym / sponsor ID
- 4-2018-0299
- Conditions
- Recurrent Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 9 May 2023 (estimated)
- Study completion
- 9 May 2023 (estimated)
- First posted
- 7 Aug 2018 (actual)
- 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.
This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| involved-field RT + standard salvage treatment | Experimental | Radiation: Involved-field radiotherapyPatients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed ovarian carcinoma
- Patients who received "standard treatment" for each stage as a primary treatment
- No. of recurrent lesions:
- If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2
- Size of recurrent lesions ≤5 cm
Key exclusion criteria (5 listed)
- Brain metastasis
- Diffuse peritoneal carcinomatosis
- Malignant pleural effusion
- History of previous salvage radiotherapy for recurrent lesions
- History of other malignancy or severe/unstable medical condition
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 |
|---|---|---|
| Involved-field radiotherapyAfter the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion. | Radiation | involved-field RT + standard salvage treatment |
Primary outcome
2-year progression-free survival (PFS)
Time frame: 2 years after radiotherapy
4 secondary outcomes
Local control of recurred lesions
Time frame: 2 years after radiotherapy
Any other new recurrence events
Time frame: 2 years after radiotherapy
Radiotherapy-related complications
Time frame: 2 years after radiotherapy
Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)
Time frame: 2 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- 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.
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 Involved-field radiotherapy in people with Recurrent Ovarian Cancer, run by Yonsei University 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 11 inclusion and 5 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 7 Aug 2018. 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 Yong Bae Kim, MD, PhD (82-2228-8095, ybkim3@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) (time frame: 2 years after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2018.