Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

Conditions
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Ovarian Cancer, Neoplasm, Ovarian, Ovarian Neoplasm, Ovary Neoplasms, Neoplasm, Ovary, Neoplasms, Ovary, Ovary Neoplasm, Neoplasms, Ovarian, Ovary Cancer, Cancer, Ovarian Stromal, Cancers, Ovary, Ovary Cancers, Cancer, Ovarian, Cancers, Ovarian, Ovarian Cancers, Cancer of Ovary, Cancer of the Ovary

Intervention / Treatment
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* Drug: chemotherapy, targeted therapeutics, immunotherapy
* Radiation: IFRT, IMRT or SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (drug treatment group)<br>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. | Drug: chemotherapy, targeted therapeutics, immunotherapy<br>* 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.<br>|
| Experimental: Group B (radiotherapy group)<br>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. | Radiation: IFRT, IMRT or SBRT<br>* IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）<br>|
| Experimental: Group C (radiotherapy + drug group)<br>Drug therapy is the same as group A; IFRT is the same as group B. | Drug: chemotherapy, targeted therapeutics, immunotherapy<br>* 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.<br>Radiation: IFRT, IMRT or SBRT<br>* IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control ( LC ) | LC will be measured from the start date of treatment until the date of progressive of the target lesion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 24 months | 
| Rate of Radiation-related Adverse Reactions | Rate of acute and late adverse reactions associated with radiotherapy | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligo-lessions, metastasis, recurrent, refractory, ovarian cancer, radiotherapy, chemotherapy