NCT04716257

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

4.7 years

First QC Date

January 15, 2021

Last Update Submit

August 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ovarian specific overall survival

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

    up to 3 years

Secondary Outcomes (4)

  • Ovarian specific objective response rate

    6 months

  • Extra-ovarian specific objective response rate

    6 months

  • Progression free survival

    6 months

  • Quality of life questionnaire

    6 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with ovarian metastatic colorectal cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Changhai Hospital, Naval Medical University

Shanghai, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

samples of ovarian metastases if available

MeSH Terms

Conditions

Krukenberg TumorColorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Signet Ring CellAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Meng Qiu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

January 14, 2021

Primary Completion

September 14, 2025

Study Completion

September 14, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations