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NCT Number: NCT04716257

A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients

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.

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Key information

Conditions

Ovarian Metastasis Adenocarcinoma Carcinoma Carcinoma, Signet Ring Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Krukenberg Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Ovarian specific overall survival

    Time frame: up to 3 years

    Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.

Secondary outcomes

  1. Ovarian specific objective response rate

    Time frame: 6 months

    Response rate of ovarian metastases to systemic chemotherapy

  2. Extra-ovarian specific objective response rate

    Time frame: 6 months

    Response rate of extra-ovarian metastases to systemic chemotherapy

  3. Progression free survival

    Time frame: 6 months

    Survival time from treatment start to disease progression or death.

  4. Quality of life questionnaire

    Time frame: 6 months

    Quality of life during treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Qiu, M.D.

CONTACT

[email protected]

+86-28-85422589

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
  • Changhai Hospital
  • Sun Yat-sen University

Registry information

Official study title

Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study

Acronym: proOMCRC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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