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

Primary Purpose

Ovarian Cancer, Neoplasm, Ovarian, Ovarian Neoplasm

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

chemotherapy, targeted therapeutics, immunotherapy

IFRT, IMRT or SBRT

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring oligo-lessions, metastasis, recurrent, refractory, ovarian cancer, radiotherapy, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

The First Affiliated Hospital of Xi'an Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Group A (drug treatment group)

Group B (radiotherapy group)

Group C (radiotherapy + drug group)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Local Control ( LC )

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 )

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 ）

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

Rate of acute and late adverse reactions associated with radiotherapy

Full Information

NCT ID

NCT05059782

First Posted

September 13, 2021

Last Updated

September 25, 2021

Sponsor

Health Science Center of Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT05059782

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 10, 2021 (Anticipated)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Health Science Center of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

oligo-lessions, metastasis, recurrent, refractory, ovarian cancer, radiotherapy, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A (drug treatment group)

Arm Type

Active Comparator

Arm Description

Arm Title

Group B (radiotherapy group)

Arm Type

Experimental

Arm Description

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.

Arm Title

Group C (radiotherapy + drug group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

chemotherapy, targeted therapeutics, immunotherapy

Intervention Description

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

Radiation

Intervention Name(s)

IFRT, IMRT or SBRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Local Control ( LC )

Description

LC will be measured from the start date of treatment until the date of progressive of the target lesion

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Progression-free Survival ( PFS )

Description

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

Time Frame

24 months

Title

Overall Survival ( OS ）

Description

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

Time Frame

24 months

Title

Rate of Radiation-related Adverse Reactions

Description

Rate of acute and late adverse reactions associated with radiotherapy

Time Frame

24 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zi Liu, Ph.d

Phone

86-18991232167

liuzmail@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Zhang, M.D

Phone

86-18220761865

zj2020email@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zi Liu, Ph.d

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Xi'an Jiao Tong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

zi liu, Ph.D

Phone

+8613630223132

liuzmail@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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