Clinical trial NCT04716257: A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients
Official title: Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Metastasis
Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
name: Changhai Hospital, Naval Medical University
First posted: 2021-01-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with ovarian metastatic colorectal cancer.

Brief summary: This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

Detailed description: This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma;
2. Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
3. Women ≥18 years of age;
4. Eastern Cooperative Oncology Group performance status score ≤2;
5. Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
6. Complete medical records;
7. Informed consent form signed.

Exclusion Criteria:

1. Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
2. Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
3. Other conditions that would influence patient compliance;
4. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.

Primary outcomes:
measure: Ovarian specific overall survival
timeFrame: up to 3 years
Secondary outcomes:
measure: Ovarian specific objective response rate
timeFrame: 6 months
measure: Extra-ovarian specific objective response rate
timeFrame: 6 months
measure: Progression free survival
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Cantón
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shenyang
country: China
facility: Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
Study officials:
References: