The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19

Gynecological Cancer Clinical Trial

Official title:

The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19, a Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341480
• Other study ID #: 2020-TJ-COVID-19
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: October 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

Description:

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; previously provisionally named 2019 novel coronavirus or 2019-nCoV) disease (COVID-19) emerged at December 2019 in Wuhan, Hubei Province, China. This infectious disease soon caused a large global outbreak and became a major public health issue. As of 19:00, 12 March 2020, the total number of confirmed cases of SARS-CoV-2 in China has reached 80982 with 3173 death, and 110 other countries have officially reported 45164 cases of SARS-CoV-2 infection with 1520 death.

In this particular time, only patients with SARS-CoV-2 or other diseases with an emergency condition were receipted by most of the hospitals in Hubei Province, even in many other regions of China. The delayed treatment for many chronic diseases, such as malignant tumors, is an increasing serious problem. One major concern was that patients with malignant tumors were generally older in age with low immunity. Preliminary study has shown that cancer patients are most susceptible to infect SARS-CoV-2 and more likely to develop a severe pneumonia. But many other researches suspected that conclusion. Moreover, many of the patients with malignant tumors are facing short term death from tumors rather than the risk of infection. Nevertheless, there is not sufficient evidence to insure the safety of chemotherapy in high-risk region of COVID-19, and there is also not sufficient information to judge which patients' tumor therapy can be appropriately delayed. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: January 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient is 18 to 80 years old female.

• Patient must have histologically confirmed either type of gynecological malignancies.

• Chemotherapy must be essential for the patient.

Exclusion Criteria:

• Diagnosed or suspected patients with covid-19 pneumonia, according to the symptom, nucleic acid tests, antibody tests for SARS-CoV-2, or CT scan of the lungs.

• Patient has a prior SARS-CoV-2 infection without clinical cure for 28 days.

• Patient has close contact with diagnosed or suspected SARS-CoV-2 infected person within 14 days.

• Patient has inadequate general condition, severe complication or organ dysfunction not fit for chemotherapy (based on the judgment of researchers).

• Patient or the family refuses to sign the informed consent.

• Patient does not cooperate in following up.

Related Conditions & MeSH terms

• COVID-19
• Gynecological Cancer

Intervention

Drug:
• Chemotherapy
Routine chemotherapy for individual tumor type.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection	Incidence rate of SARS-CoV-2 infection within the whole period of the study.	through study completion, an average of 3 months.
Secondary	Tumor response	Tumor response by determining changes (PD, SD, PR, CR) according to Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1	6 weeks after enrollment.
Secondary	Safety and tolerability of chemotherapy as measured by the Common Terminology	Safety and tolerability of chemotherapy as measured by the Common Terminology Criteria for Adverse Events (version 4.0)	through study completion, an average of 3 months.
Secondary	Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)	To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life.; questionnaire core-30 (QLQ-C30).	through study completion, an average of 3 months.