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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059782
• Other study ID #: GCR-04
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cancer of Ovary
• Cancer of the Ovary
• Cancer, Ovarian
• Carcinoma, Ovarian Epithelial
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Ovarian
• Ovarian Cancer
• Ovarian Cancers
• Ovarian Neoplasm
• Ovarian Neoplasms
• Ovary Cancer
• Ovary Neoplasm
• Ovary Neoplasms

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