Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03785574

Collaborator

(none)

Enrollment

Location

Arms

80.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule <1.0cm will directly treated as group C

Condition or Disease	Intervention/Treatment	Phase
Hydatidiform Mole Gestational Trophoblastic Neoplasia	Other: Follow up Drug: chemotherapy	N/A

Detailed Description

The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.

Lung nodule <1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total. Lung nodule <1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total. Lung nodule <1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial

Actual Study Start Date :

Dec 24, 2018

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A:chemotherapy immediately Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO	Drug: chemotherapy First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO Other Names: mtx for low risk
Experimental: B:follow up B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.	Other: Follow up the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree. Other Names: not chemotherapy immediately Drug: chemotherapy First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO Other Names: mtx for low risk

Arm

Intervention/Treatment

Active Comparator: A:chemotherapy immediately

Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Drug: chemotherapy

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Other Names:

mtx for low risk

Experimental: B:follow up

B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.

Other: Follow up

the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.

Other Names:

not chemotherapy immediately

Drug: chemotherapy

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Other Names:

mtx for low risk

Outcome Measures

Primary Outcome Measures

chemotherapy cycles [20 month]
chemotherapy cycles to achieve hCG normalization and failure to first line
hCG declined to normal spontaneously of group B [20]
The proportion of patients with hCG level declined to normal spontaneously of group B

Secondary Outcome Measures

follow up of lung nodules [32 month]
the change of the lung nodules during follow up in group B and C

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

pathologic confirmed hydatidiform mole
the lung nodule was detected by lung CT at the suction evacuation of molar pregnancy or during weekly hCG surveillance and lung metastasis cannot be excluded
the hCG level do not meet FIGO diagnostic criteria of GTN
good compliance
consent informed

Exclusion Criteria:

history of lung nodule
lung nodule was conformed as other diseases such as Tuberculosis, pneumonia
already accepted with chemotherapy or hysterectomy
pathologic confirmed GTN
immunosuppressive diseases status or take immunosuppressive drugs
Participating in other clinical trials
unable or unwilling to sign informed consent
cannot or unwilling to comply with research requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weiguo Lv	Hangzhou	Zhejiang	China

Sponsors and Collaborators

Women's Hospital School Of Medicine Zhejiang University

Investigators

Principal Investigator: Xing Xie, Women's Hospital, Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xing Xie, Professor, Women's Hospital School Of Medicine Zhejiang University

ClinicalTrials.gov Identifier:

NCT03785574

Other Study ID Numbers:

CSEM 012

First Posted:

Dec 24, 2018

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xing Xie, Professor, Women's Hospital School Of Medicine Zhejiang University

Pulmonary Nodule

Chemotherapy

Chorionic Gonadotrophin

Additional relevant MeSH terms:

Gestational Trophoblastic Disease

Hydatidiform Mole

Study Results

No Results Posted as of Oct 29, 2021