A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Metastasis, Colorectal Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
Overview
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.
Primary outcome measures
- Ovarian specific overall survival [Time frame: up to 3 years]
Secondary outcome measures (4)
- Ovarian specific objective response rate [Time frame: 6 months]
- Extra-ovarian specific objective response rate [Time frame: 6 months]
- Progression free survival [Time frame: 6 months]
- Quality of life questionnaire [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Histologically confirmed colorectal adenocarcinoma;
- Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
- Women ≥18 years of age;
- Eastern Cooperative Oncology Group performance status score ≤2;
- Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
- Complete medical records;
- Informed consent form signed.
Exclusion criteria
- Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
- Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
- Other conditions that would influence patient compliance;
- Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 4 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute — Shenyang
- West China Hospital of Sichuan University — Chengdu
- Changhai Hospital, Naval Medical University — Shanghai
Identifiers
NCT: NCT04716257 · 20201296