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

Not Applicable

Recruiting

• Conditions: Ovary Neoplasm; Neoplasms, Ovarian; Cancers, Ovary; Ovarian Cancers; Ovarian Neoplasm; Ovary Neoplasms; Neoplasm, Ovary; Ovary Cancer; Cancer, Ovarian; Ovarian Cancer
• Interventions: Drug: chemotherapy, targeted therapeutics, immunotherapy; Radiation: IFRT, IMRT or SBRT

• Registration Number: NCT05059782
• Lead Sponsor: Health Science Center of Xi'an Jiaotong University

Brief 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 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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-25
• Last Update Submitted: 2021-09-25
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Study Start: 2021-10-10
• Primary Completion: 2023-02-28
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Age ≥18;
2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
5. Cooperative Oncology Group-Status (ECOG Status) score 0-2;
6. Expected survival ≥3 months;
7. Feasible abdomen and pelvic cavity MRI/CT;
8. Good compliance, signed informed consent voluntarily.

Exclusion Criteria

1. Previous radiotherapy at the target lesion site;
2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
3. Human immunodeficiency virus (HIV) infected persons;
4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);
7. neurological or mental disorders that affect cognitive ability;
8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;
9. those who cannot follow up regularly as prescribed by the doctor;
10. Other reasons not suitable for participating in this study as judged by the researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (drug treatment group)	chemotherapy, targeted therapeutics, immunotherapy	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.
Group B (radiotherapy group)	IFRT, IMRT or SBRT	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.
Group C (radiotherapy + drug group)	chemotherapy, targeted therapeutics, immunotherapy	Drug therapy is the same as group A; IFRT is the same as group B.
Group C (radiotherapy + drug group)	IFRT, IMRT or SBRT	Drug therapy is the same as group A; IFRT is the same as group B.

Primary Outcome Measures

Name	Time	Method
Local Control ( LC )	6 months	LC will be measured from the start date of treatment until the date of progressive of the target lesion

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival ( PFS )	24 months	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
Overall Survival ( OS ）	24 months	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
Rate of Radiation-related Adverse Reactions	24 months	Rate of acute and late adverse reactions associated with radiotherapy

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China