NCT05059782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

September 13, 2021

Last Update Submit

September 25, 2021

Conditions

Ovarian CancerNeoplasm, OvarianOvarian NeoplasmOvary NeoplasmsNeoplasm, OvaryNeoplasms, OvaryOvary NeoplasmNeoplasms, OvarianOvary CancerCancer, Ovarian StromalCancers, OvaryOvary CancersCancer, OvarianCancers, OvarianOvarian CancersCancer of OvaryCancer of the Ovary

Keywords

oligo-lessionsmetastasisrecurrentrefractoryovarian cancerradiotherapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Progression-free Survival ( PFS )

    24 months

  • Overall Survival ( OS ）

    24 months

  • Rate of Radiation-related Adverse Reactions

    24 months

Study Arms (3)

Group A (drug treatment group)

ACTIVE COMPARATOR

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

Group B (radiotherapy group)

EXPERIMENTAL

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

Group C (radiotherapy + drug group)

EXPERIMENTAL

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

Drug: chemotherapy, targeted therapeutics, immunotherapyRadiation: IFRT, IMRT or SBRT

Interventions

chemotherapy, targeted therapeutics, immunotherapyDRUG

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 A (drug treatment group)Group C (radiotherapy + drug group)
IFRT, IMRT or SBRTRADIATION

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

Group B (radiotherapy group)Group C (radiotherapy + drug group)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasmsNeoplasm MetastasisRecurrence

Interventions

Drug TherapyImmunotherapyRadiotherapy, Intensity-ModulatedRadiosurgery

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

TherapeuticsImmunomodulationBiological TherapyRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Zi Liu, Ph.d

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zi Liu, Ph.d

CONTACT

86-18991232167liuzmail@163.com

Jing Zhang, M.D

CONTACT

86-18220761865zj2020email@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 28, 2021

Study Start

October 10, 2021

Primary Completion

February 28, 2023

Study Completion

September 1, 2024

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

CN(1)