Recurrent Epithelial Ovarian CancerSABR-ROCNCT05444270
Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer
A study testing Standard salvage therapy and Standard salvage therapy + SABR in people with Recurrent Epithelial Ovarian Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Rationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Recurrent Epithelial Ovarian Cancer
- What is being tested?
- Standard salvage therapy and Standard salvage therapy + SABR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pathologically confirmed epithelial ovarian cancer
- Should have completed standard treatment for the primary tumor initially. (In the case of advanced ovarian cancer, maximal debulking operation and adjuvant platinum-based chemotherapy are performed according to the stage)
- Number of metastases allowed: ≤ 10 (Adjacent lesions can be counted as a single lesion if possible to be included in a single radiotherapy treatment plan) (left cervical lymph node, right cervical lymph node, center of the left lung, periphery of the left lung, left pleura, center of the right lung, periphery of the right lung, right pleura, mediastinal lymph node, left lobe of the liver, right lobe of the liver, perihepatic space, spleen, perisplenic space, within 2 vertebrae above or below based on the spine with the lesion, abdominal cavity, pelvic cavity, paraaortic lymph node, and pelvic lymph nodes)
- Maximum diameter of each metastasis site of gross tumor ≤ 5 cm
- Age ≥ 19 year old
- Sufficient bone marrow function on tests performed within 60 days prior to study enrollment, including:
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- Absolute neutrophil count (ANC) ≥ 500 / mm3
- Platelet ≥ 50,000 / mm3
- Hb ≥ 8.0 g / dl (Treatments such as blood transfusions to maintain hemoglobin count are permitted)
- Zubrod daily living performance ≤ 2 within 60 days prior to study enrollment
- Subjects must submit research-related informed consent prior to participation in the study
Who cannot join
- Brain metastasis
- Diffuse peritoneal carcinomatosis
- Exudative, hematological, or cytologically proven malignant exudate (Malignant pleural effusion)
- If previously treated with radiation therapy to metastases
- When targeting is difficult because the boundary of the metastasis site is not clear
- Coexisting or previous invasive cancer (excluding Thyroid cancer, Cervix CIS, basal cell carcinoma of skin, early gastric cancer) has not been disease-free for more than 3 years.
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- Pregnancy
- Serious comorbidities defined as below
- Unstable angina or congestive heart failure requiring hospitalization within the last 6 months
- Deep myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
- At the time of enrollment, exacerbation of chronic obstructive pulmonary disease or other respiratory disease that requires hospitalization or makes it difficult to proceed with treatment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Yong Bae Kim, ybkim3@yuhs.ac
About this study
Official title: Prospective Multi-institutional Phase III Trial of Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer
Rationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy.
In the 1980~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, provided chemotherapy holiday in selected cases, but did not prevent out-field progression. Stereotactic ABlative Radiotherapy (SABR) is the latest treatment using an intensity modulated technique to increase the fractional dose, reduces the number of treatments, and destroys the tumor with high accuracy. SABR-COMET study, a representative clinical study, showed a significant increase in overall survival in solid cancers.
Read more
Objectives The primary objective; to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer.
The secondary objectives;
- to check whether it significantly affects quality of life (Health-related QoL), patient-reported outcome (PRO)
- to develop an deep learning-based predictive model for the treatment response of ovarian cancer subjects using radiomic and genomic analysis.
Study design Arm 1; Standard salvage therapy Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities.
Arm 2; Standard salvage therapy+ SABR Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor.
Stratification factors
- The number of No ascites, Platinum-sensitive, Normal CA125 and ECOG０-１; 0~3 vs. 4
- Location of the lesion; Lymph node lesion vs. Non-lymph node lesion
- PARP inhibitor; Used vs. Not used
Randomization Arm 1 : Arm 2 = 1 : 2
Estimated Accrual :
- The sample size 270 was calculated by setting the sample size to a Type I error rate (α) of 0.05 and Statistical Power of 80% using 2-Sided Equity and log-rank test.
- Accurate time: 2 years, Follow-up: 3 years (total 5 years)
- Alpha = 0.05, Power = 80%
- 1 year drop-out: 5% per group
- 3 year survival proportion: RT group 74.42%, No RT group 58%
- Arm 1: Arm 2 = 1 : 2 ratio
Read the detailed description
Treatment Plan Arm 2; SABR Number of Fractions Preferred Doses Acceptable Doses
1 20 Gy 16-24 Gy 3 30 Gy 24-33 Gy 5 35 Gy 25-40 Gy 10 40 Gy 35-45 Gy
Patient Evaluation:
- Interviews
- It was performed 3, 6, 9, 12, 18, 24, 30, and 36 months after the end of treatment.
- Medical history listening, physical examination and assessment of all possible side effects
- The relevant examination can be prescribed if necessary.
- Imaging examination
- one of CT or PET-CT including areas suspected of recurrence or treatment is possible.
- If PET-CT was not performed within two months before treatment, it is recommended to perform PET-CT before treatment NOTE: Before treatment, it is recommended to perform the same examination as the imaging test that evaluated the treatment site.
- Tumor marker CA125 examination: performed on every visit after radiation therapy.
- Survey EORTC-QLQ-C30 questionnaire; prior to radiation therapy, 12, 24, and 36 months after treatment FACIT-TS-G (Arm 2 subjects); before radiation therapy, 12, 24, and 36 months after treatment.
- Conditions
- Recurrent Epithelial Ovarian Cancer
- Being tested
- Standard salvage therapy, Standard salvage therapy + SABR
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard salvage therapyOther
Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities.
Standard salvage therapy + SABRRadiation
Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor.
| Study group | Role | What they receive |
|---|---|---|
| Standard salvage therapy | Active comparator | Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. Receives: Other: Standard salvage therapy |
| Standard salvage therapy + SABR | Experimental | Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. Receives: Radiation: Standard salvage therapy + SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer
Measured: 3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start26 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Recurrent Epithelial 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 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
- NCT05444270
- Sponsor's protocol ID
- 4-2022-0286
- Acronym
- SABR-ROC
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park S, Kim H, Wee CW, Kim YS, Choi JH, Kim YS, Lee JH, Choi Y, Kim JH, Cho Y, Kim HJ, Park YJ, Park W, Eom KY, Kim YH, Kim YB. Radiotherapy quality assurance program of ongoing clinical trial using stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC): a dummy run study of a prospective, randomized, multicenter phase III trial (KGOG 3064/KROG 2204). BMC Cancer. 2025 Aug 18;25(1):1336. doi: 10.1186/s12885-025-13892-9.
PubMed 40826041Kim YB, Byun HK, Wee CW, Kim H, Kim S, Yang G, Kim J, Park SJ, Lee JY. Study protocol for prospective multi-institutional phase III trial of standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC). BMC Cancer. 2023 Oct 20;23(1):1014. doi: 10.1186/s12885-023-11407-y.
PubMed 37864152
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-institutional Phase III Trial of Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05444270
- Acronym / sponsor ID
- SABR-ROC / 4-2022-0286
- Conditions
- Recurrent Epithelial Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2022 (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.
Rationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy.
In the 1980~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, provided chemotherapy holiday in selected cases, but did not prevent out-field progression. Stereotactic ABlative Radiotherapy (SABR) is the latest treatment using an intensity modulated technique to increase the fractional dose, reduces the number of treatments, and destroys the tumor with high accuracy. SABR-COMET study, a representative clinical study, showed a significant increase in overall survival in solid cancers.
Objectives The primary objective; to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer.
The secondary objectives;
- to check whether it significantly affects quality of life (Health-related QoL), patient-reported outcome (PRO)
- to develop an deep learning-based predictive model for the treatment response of ovarian cancer subjects using radiomic and genomic analysis.
Study design Arm 1; Standard salvage therapy Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities.
Arm 2; Standard salvage therapy+ SABR Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor.
Stratification factors
- The number of No ascites, Platinum-sensitive, Normal CA125 and ECOG０-１; 0~3 vs. 4
- Location of the lesion; Lymph node lesion vs. Non-lymph node lesion
- PARP inhibitor; Used vs. Not used
Randomization Arm 1 : Arm 2 = 1 : 2
Estimated Accrual :
- The sample size 270 was calculated by setting the sample size to a Type I error rate (α) of 0.05 and Statistical Power of 80% using 2-Sided Equity and log-rank test.
- Accurate time: 2 years, Follow-up: 3 years (total 5 years)
- Alpha = 0.05, Power = 80%
- 1 year drop-out: 5% per group
- 3 year survival proportion: RT group 74.42%, No RT group 58%
- Arm 1: Arm 2 = 1 : 2 ratio
Detailed description
Treatment Plan Arm 2; SABR Number of Fractions Preferred Doses Acceptable Doses
1 20 Gy 16-24 Gy 3 30 Gy 24-33 Gy 5 35 Gy 25-40 Gy 10 40 Gy 35-45 Gy
Patient Evaluation:
- Interviews
- It was performed 3, 6, 9, 12, 18, 24, 30, and 36 months after the end of treatment.
- Medical history listening, physical examination and assessment of all possible side effects
- The relevant examination can be prescribed if necessary.
- Imaging examination
- one of CT or PET-CT including areas suspected of recurrence or treatment is possible.
- If PET-CT was not performed within two months before treatment, it is recommended to perform PET-CT before treatment NOTE: Before treatment, it is recommended to perform the same examination as the imaging test that evaluated the treatment site.
- Tumor marker CA125 examination: performed on every visit after radiation therapy.
- Survey EORTC-QLQ-C30 questionnaire; prior to radiation therapy, 12, 24, and 36 months after treatment FACIT-TS-G (Arm 2 subjects); before radiation therapy, 12, 24, and 36 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard salvage therapy | Active comparator | Other: Standard salvage therapySubjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. |
| Standard salvage therapy + SABR | Experimental | Radiation: Standard salvage therapy + SABRSubjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed epithelial ovarian cancer
- Should have completed standard treatment for the primary tumor initially. (In the case of advanced ovarian cancer, maximal debulking operation and adjuvant platinum-based chemotherapy are performed according to the stage)
- Number of metastases allowed: ≤ 10 (Adjacent lesions can be counted as a single lesion if possible to be included in a single radiotherapy treatment plan) (left cervical lymph node, right cervical lymph node, center of the left lung, periphery of the left lung, left pleura, center of the right lung, periphery of the right lung, right pleura, mediastinal lymph node, left lobe of the liver, right lobe of the liver, perihepatic space, spleen, perisplenic space, within 2 vertebrae above or below based on the spine with the lesion, abdominal cavity, pelvic cavity, paraaortic lymph node, and pelvic lymph nodes)
- Maximum diameter of each metastasis site of gross tumor ≤ 5 cm
- Age ≥ 19 year old
Key exclusion criteria (12 listed)
- Brain metastasis
- Diffuse peritoneal carcinomatosis
- Exudative, hematological, or cytologically proven malignant exudate (Malignant pleural effusion)
- If previously treated with radiation therapy to metastases
- When targeting is difficult because the boundary of the metastasis site is not clear
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 |
|---|---|---|
| Standard salvage therapySubjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. | Other | Standard salvage therapy |
| Standard salvage therapy + SABRSubjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. | Radiation | Standard salvage therapy + SABR |
Primary outcome
overall survival (OS)
Time frame: 3year
to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 40826041Park S, Kim H, Wee CW, Kim YS, Choi JH, Kim YS, Lee JH, Choi Y, Kim JH, Cho Y, Kim HJ, Park YJ, Park W, Eom KY, Kim YH, Kim YB. Radiotherapy quality assurance program of ongoing clinical trial using stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC): a dummy run study of a prospective, randomized, multicenter phase III trial (KGOG 3064/KROG 2204). BMC Cancer. 2025 Aug 18;25(1):1336. doi: 10.1186/s12885-025-13892-9.
- Derived from this study: PubMed 37864152Kim YB, Byun HK, Wee CW, Kim H, Kim S, Yang G, Kim J, Park SJ, Lee JY. Study protocol for prospective multi-institutional phase III trial of standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC). BMC Cancer. 2023 Oct 20;23(1):1014. doi: 10.1186/s12885-023-11407-y.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard salvage therapy and Standard salvage therapy + SABR in people with Recurrent Epithelial 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 12 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: looking for participants now, as of the sponsor's last update on 24 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Bae Kim (82-2-2228-8095, ybkim3@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 3year). 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 NCT05444270, 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 24 Nov 2023.