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

Sponsor

Health Science Center of Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05059782

Collaborator

(none)

150

Enrollment

Location

Arms

34.7

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: chemotherapy, targeted therapeutics, immunotherapy Radiation: IFRT, IMRT or SBRT	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group A (drug treatment group)

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

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.

Experimental: Group B (radiotherapy group)

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

IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）

Experimental: Group C (radiotherapy + drug group)

Drug therapy is the same as group A; IFRT is the same as group B.

Drug: chemotherapy, targeted therapeutics, immunotherapy

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.

Radiation: IFRT, IMRT or SBRT

IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.