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

NCT ID: NCT05059782

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2024-09-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

chemotherapy, targeted therapeutics, immunotherapy

Intervention Type: DRUG

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 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 Type: EXPERIMENTAL

IFRT, IMRT or SBRT

Intervention Type: RADIATION

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

Group C (radiotherapy + drug group)

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

Group Type: EXPERIMENTAL

chemotherapy, targeted therapeutics, immunotherapy

Intervention Type: DRUG

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 SBRT

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: DRUG

IFRT, IMRT or SBRT

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Liu Zi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zi Liu, Ph.d

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zi Liu, Ph.d

Role: CONTACT

liuzmail@163.com

86-18991232167

Jing Zhang, M.D

Role: CONTACT

zj2020email@163.com

86-18220761865

Facility Contacts

zi liu, Ph.D

Role: primary

liuzmail@163.com

+8613630223132

Other Identifiers

GCR-04

Identifier Type: -

Identifier Source: org_study_id