Ovarian CancerNCT05059782
Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer
A study testing chemotherapy, targeted therapeutics, immunotherapy and IFRT, IMRT or SBRT in people with Ovarian Cancer and Neoplasm, Ovarian, run by Xi'an Jiaotong University at 1 site in China.
Trial summary
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Neoplasm, Ovarian, Ovarian Neoplasm
- What is being tested?
- chemotherapy, targeted therapeutics, immunotherapy and IFRT, IMRT or SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2021to 1 Sep 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18;
- Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
- Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
- No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
- Cooperative Oncology Group-Status (ECOG Status) score 0-2;
- Expected survival ≥3 months;
- Feasible abdomen and pelvic cavity MRI/CT;
- Good compliance, signed informed consent voluntarily.
Who cannot join
- Previous radiotherapy at the target lesion site;
- History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
- Human immunodeficiency virus (HIV) infected persons;
- active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
- suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
- patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);
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- neurological or mental disorders that affect cognitive ability;
- Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;
- those who cannot follow up regularly as prescribed by the doctor;
- Other reasons not suitable for participating in this study as judged by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
zi liu, Ph.D, +8613630223132, liuzmail@163.com
About this study
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.
Read the detailed description
The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.
- Conditions
- Ovarian Cancer, Neoplasm, Ovarian, Ovarian Neoplasm, Ovary Neoplasms, Neoplasm, Ovary, Neoplasms, Ovary
- Being tested
- chemotherapy, targeted therapeutics, immunotherapy, IFRT, IMRT or SBRT
- Keywords
- oligo-lessions, metastasis, recurrent, refractory, ovarian cancer, radiotherapy, chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy, targeted therapeutics, immunotherapyDrug
Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
IFRT, IMRT or SBRTRadiation
IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）
| Study group | Role | What they receive |
|---|---|---|
| Group A (drug treatment group) | Active comparator | Group A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary. Receives: Drug: chemotherapy, targeted therapeutics, immunotherapy |
| Group B (radiotherapy group) | Experimental | IFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent. Receives: Radiation: IFRT, IMRT or SBRT |
| Group C (radiotherapy + drug group) | Experimental | Drug therapy is the same as group A; IFRT is the same as group B. Receives: Drug: chemotherapy, targeted therapeutics, immunotherapy; Radiation: IFRT, IMRT or SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control ( LC )
LC will be measured from the start date of treatment until the date of progressive of the target lesion
Measured: 6 months
Secondary outcomes (3)
Progression-free Survival ( PFS )
PFS is defined as the time from first day of treatment until the first date of either objective disease progression or death due to any cause
Measured: 24 months
Overall Survival ( OS ）
OS is defined as the time from first day of treatment until the date of death due to any cause or the deadline for the study
Measured: 24 months
Rate of Radiation-related Adverse Reactions
Rate of acute and late adverse reactions associated with radiotherapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start10 Oct 2021 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group A (drug treatment group) : Patients accept paclitaxel + platinum or paclitaxel single drug chemotherapy of which paclitaxel 135-175mg/m2, carboplatin AUC=5, cisplatin 40-60mg/m2. The treatment should be repeated every 3 weeks. Other second-line and third-line chemotherapy regimens (dose is not specified) are also allowed. Targeted, immunological or PARPi drugs can be added based on pathological and genetic test results until disease progression, unacceptable toxicity or informed consent withdrawal. Group B (radiotherapy group): IFRT, IMRT or SBRT is applied. Radiotherapy regimen: Involving field PGTV 60Gy-70Gy, 2-3Gy/f,5 times/week. External irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent. Group C (radiotherapy + drug group) : IFRT is the same as group B;Drug therapy: same as group A.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zi, Xi'an Jiaotong University
- Investigators
- Zi Liu, Ph.d, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059782
- Sponsor's protocol ID
- GCR-04
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05059782
- Acronym / sponsor ID
- GCR-04
- Conditions
- Ovarian Cancer, Neoplasm, Ovarian, Ovarian Neoplasm, Ovary Neoplasms, Neoplasm, Ovary, Neoplasms, Ovary
- Keywords
- oligo-lessions, metastasis, recurrent, refractory, ovarian cancer, radiotherapy, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Sep 2021 (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.
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.
Detailed description
The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group A (drug treatment group) : Patients accept paclitaxel + platinum or paclitaxel single drug chemotherapy of which paclitaxel 135-175mg/m2, carboplatin AUC=5, cisplatin 40-60mg/m2. The treatment should be repeated every 3 weeks. Other second-line and third-line chemotherapy regimens (dose is not specified) are also allowed. Targeted, immunological or PARPi drugs can be added based on pathological and genetic test results until disease progression, unacceptable toxicity or informed consent withdrawal. Group B (radiotherapy group): IFRT, IMRT or SBRT is applied. Radiotherapy regimen: Involving field PGTV 60Gy-70Gy, 2-3Gy/f,5 times/week. External irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent. Group C (radiotherapy + drug group) : IFRT is the same as group B;Drug therapy: same as group A.
| Arm | Type | Receives |
|---|---|---|
| Group A (drug treatment group) | Active comparator | Drug: chemotherapy, targeted therapeutics, immunotherapyGroup A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary. |
| Group B (radiotherapy group) | Experimental | Radiation: IFRT, IMRT or SBRTIFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent. |
| Group C (radiotherapy + drug group) | Experimental | Drug: chemotherapy, targeted therapeutics, immunotherapy, Radiation: IFRT, IMRT or SBRTDrug therapy is the same as group A; IFRT is the same as group B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18;
- Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
- Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
- No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
- Cooperative Oncology Group-Status (ECOG Status) score 0-2;
Key exclusion criteria (10 listed)
- Previous radiotherapy at the target lesion site;
- History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
- Human immunodeficiency virus (HIV) infected persons;
- active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
- suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
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 |
|---|---|---|
| chemotherapy, targeted therapeutics, immunotherapyChemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary. | Drug | Group A (drug treatment group), Group C (radiotherapy + drug group) |
| IFRT, IMRT or SBRTIFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy） | Radiation | Group B (radiotherapy group), Group C (radiotherapy + drug group) |
Primary outcome
Local Control ( LC )
Time frame: 6 months
LC will be measured from the start date of treatment until the date of progressive of the target lesion
3 secondary outcomes
Progression-free Survival ( PFS )
Time frame: 24 months
Overall Survival ( OS ）
Time frame: 24 months
Rate of Radiation-related Adverse Reactions
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
Zi Liu, Ph.d principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy, targeted therapeutics, immunotherapy and IFRT, IMRT or SBRT in people with Ovarian Cancer and Neoplasm, Ovarian, run by Xi'an Jiaotong University at 1 site in China.
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 8 inclusion and 10 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 28 Sep 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi Liu, Ph.d (86-18991232167, liuzmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control ( LC ) (time frame: 6 months). 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 28 Sep 2021.