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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05059782
Other study ID # GCR-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date September 1, 2024

Study information

Verified date September 2021
Source Health Science Center of Xi'an Jiaotong University
Contact Zi Liu, Ph.d
Phone 86-18991232167
Email liuzmail@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 participation.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2024
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

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)

Locations

Country Name City State
China The First Affiliated Hospital of Xi'an Jiao Tong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Health Science Center of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Rate of Radiation-related Adverse Reactions Rate of acute and late adverse reactions associated with radiotherapy 24 months
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