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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gynecological Cancer
• Intervention / Treatment: Drug: Chemotherapy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 305

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecological malignancy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy group; Routine chemotherapy every 3 weeks for 2 cycles, and follow up for 2 weeks after discharge from hospital. Total observation duration is 6 weeks.	Drug: Chemotherapy; Routine chemotherapy for individual tumor type.
Control group; No treatment, based on patient's choice. Total observation duration is 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Chemotherapy; Gynecological cancer
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-TJ-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No