Ovarian Cancer (Epithelial)NCT02135523
The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial
A study testing involved-field radiation therapy in people with Ovarian Cancer (Epithelial), run by Yonsei University at 1 site in South Korea.
Trial summary
1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional phase 2 clinical trial 2. Study period: 2014.04~2018.04 3. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Cancer (Epithelial)
- What is being tested?
- involved-field radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2014to 8 Jan 2018
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 19 years
- ECOG performance status 0-1
- pathologically confirmed malignant epithelial ovarian cancer
- surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
- at least on of the following: consolidation therapy for grossly negative condition prior large tumor after surgery and adjuvant chemotherapy, residual tumor after adjuvant or salvage chemotherapy, local recurrent tumor after adjuvant or salvage chemotherapy, consolidation therapy after surgical removal of recurrent tumor
Who cannot join
- diffuse peritoneal seeding
- brain or bone metastasis
- prior invasive malignancy (except controlled skin cancer, carcinoma in situ of the cervix and early thyroid and gastric cancer) unless disease free for a minimum of 5 years prior to study entry
- serious underlying medical disease
- not providing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
- Title: The efficacy of involved-field radiation therapy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional phase 2 clinical trial
- Study period: 2014.04~2018.04
- Objective: To determine whether involved-field radiation therapy will prove to be improve 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.
- Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)
- Planned number of patients
- YUHS database have 149 FIGO stage III patients treated with debulking surgery and adjuvant platinum-based chemotherapy 2.
- Of these patients, 90 patients experienced locoregional failures, and then the investigators selected 44 patients who could be treated effectively with IFRT based on MDACC suggestion.
- Median interval to failure was 9 months in these patients
- Hypothesis; IFRT reduces 44% hazard of progression compared with patients without IFRT
- Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power = 0.80 Null progression-free median survival = 9 mo Alt progression-free median survival = 16 mo Calculated sample number = total 27 patients Drop rate = 10% • Total sample number = 30 patients Estimated Enrollment : 30 participants
Read more
Drop rate = 10%
- Total sample number = 70 patients 6. Radiation therapy: Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy with 1.8-2.0 Gy fraction, five times per week for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment
- Target volume
- directed to gross disease plus a high-risk clinical target volume (CTV) that included the postoperative bed or the prechemotherapy extent of disease with a 1- to 1.5-cm margin, excluding uninvolved clinical structures
- Additional CTVs were designated according to the risks of microscopic disease spread, proximity to critical structures, and other risk factors for complications.
- Nodal CTVs included grossly involved lymph node sites, extending to cover adjacent uninvolved regions.
- Modality; 3-dimensional conformal RT including electron, intensity-modulated RT, proton beam RT 7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy 8. Key words: ovarian cancer, involved-field radiation therapy, progression free survival
- Conditions
- Ovarian Cancer (Epithelial)
- Being tested
- involved-field radiation therapy
- Keywords
- ovarian cancer, involved-field radiation therapy, progression free survival
- 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 radiation therapyRadiation
Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment. Patients will be treated with 1.8-2.0Gy fraction, five times per week. It starts 2 weeks later of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| single arm: involved-field radiation therapy group | Experimental | Not described Receives: Radiation: involved-field radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year progression free survival(PFS) after involved-field radiation therapy
To determine whether involved-field radiation therapy will prove to be improved 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.
Measured: Participants will be followed for 2 year after radiation therapy
Secondary outcomes (4)
overall survival
Measured: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
chemotherapy-free survival
Measured: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
in-field disease control
Measured: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
serious adverse event
Measured: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start6 Feb 2014
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer (Epithelial)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135523
- Sponsor's protocol ID
- 4-2013-0896
- Status last verified
- May 2018
- First submitted
- 23 Apr 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial
- ClinicalTrials.gov ID
- NCT02135523
- Acronym / sponsor ID
- 4-2013-0896
- Conditions
- Ovarian Cancer (Epithelial)
- Keywords
- ovarian cancer, involved-field radiation therapy, progression free survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 12 May 2014 (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.
- Title: The efficacy of involved-field radiation therapy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional phase 2 clinical trial
- Study period: 2014.04~2018.04
- Objective: To determine whether involved-field radiation therapy will prove to be improve 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.
- Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)
- Planned number of patients
- YUHS database have 149 FIGO stage III patients treated with debulking surgery and adjuvant platinum-based chemotherapy 2.
- Of these patients, 90 patients experienced locoregional failures, and then the investigators selected 44 patients who could be treated effectively with IFRT based on MDACC suggestion.
- Median interval to failure was 9 months in these patients
- Hypothesis; IFRT reduces 44% hazard of progression compared with patients without IFRT
- Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power = 0.80 Null progression-free median survival = 9 mo Alt progression-free median survival = 16 mo Calculated sample number = total 27 patients Drop rate = 10% • Total sample number = 30 patients Estimated Enrollment : 30 participants
Drop rate = 10%
- Total sample number = 70 patients 6. Radiation therapy: Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy with 1.8-2.0 Gy fraction, five times per week for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment
- Target volume
- directed to gross disease plus a high-risk clinical target volume (CTV) that included the postoperative bed or the prechemotherapy extent of disease with a 1- to 1.5-cm margin, excluding uninvolved clinical structures
- Additional CTVs were designated according to the risks of microscopic disease spread, proximity to critical structures, and other risk factors for complications.
- Nodal CTVs included grossly involved lymph node sites, extending to cover adjacent uninvolved regions.
- Modality; 3-dimensional conformal RT including electron, intensity-modulated RT, proton beam RT 7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy 8. Key words: ovarian cancer, involved-field radiation therapy, progression free survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm: involved-field radiation therapy group | Experimental | Radiation: involved-field radiation therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age> 19 years
- ECOG performance status 0-1
- pathologically confirmed malignant epithelial ovarian cancer
- surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
- at least on of the following: consolidation therapy for grossly negative condition prior large tumor after surgery and adjuvant chemotherapy, residual tumor after adjuvant or salvage chemotherapy, local recurrent tumor after adjuvant or salvage chemotherapy, consolidation therapy after surgical removal of recurrent tumor
Key exclusion criteria (5 listed)
- diffuse peritoneal seeding
- brain or bone metastasis
- prior invasive malignancy (except controlled skin cancer, carcinoma in situ of the cervix and early thyroid and gastric cancer) unless disease free for a minimum of 5 years prior to study entry
- serious underlying medical disease
- not providing informed consent
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 radiation therapyParticipants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment. Patients will be treated with 1.8-2.0Gy fraction, five times per week. It starts 2 weeks later of chemotherapy. | Radiation | single arm: involved-field radiation therapy group |
Primary outcome
Two-year progression free survival(PFS) after involved-field radiation therapy
Time frame: Participants will be followed for 2 year after radiation therapy
To determine whether involved-field radiation therapy will prove to be improved 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.
4 secondary outcomes
overall survival
Time frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
chemotherapy-free survival
Time frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
in-field disease control
Time frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
serious adverse event
Time frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing involved-field radiation therapy in people with Ovarian Cancer (Epithelial), 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 5 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: finished, as of the sponsor's last update on 17 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year progression free survival(PFS) after involved-field radiation therapy (time frame: Participants will be followed for 2 year after radiation therapy). 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 17 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.