Clinical trial NCT05059782: 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
Overall status: UNKNOWN
Phase: NA
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
Keywords: oligo-lessions
metastasis
recurrent
refractory
ovarian cancer
radiotherapy
chemotherapy
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local Control ( LC )
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free Survival ( PFS )
timeFrame: 24 months
measure: Overall Survival ( OS ）
timeFrame: 24 months
measure: Rate of Radiation-related Adverse Reactions
timeFrame: 24 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zi Liu, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: