Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

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

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

Study Overview

• Status: Recruiting
• Conditions: Hydatidiform Mole; Gestational Trophoblastic Neoplasia
• Intervention / Treatment: Drug: chemotherapy; Other: Follow up

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao Li, dortor; Phone Number: 008657189992206; Email: 5198008@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Weiguo Lv
      • Contact: Weiguo Lv, Doctor; Phone Number: 8657187061501; Email: lixsure@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

Eligible patients have to meet all of the following criteria:

1. Pathologically confirmed HM.
2. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
3. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
4. The patients are willing to compliant with the study protocol and be followed up at regular intervals.
5. The patients agree to sign an informed consent form.

Exclusion criteria

1. The patients with a previous history of lung nodules.
2. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
3. The patients have undergone prophylactic hysterectomy or chemotherapy.
4. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
5. Patients have immunosuppressive diseases or take immunosuppressants.
6. Patients are participating in other clinical trials at same time.
7. Patients were unable or unwilling to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.	Drug: chemotherapy; First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO; Other Names: mtx for low risk; Other: Follow up; the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.; Other Names: not chemotherapy immediately
Experimental: C: lung nodule diameter <1.0 cm; C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.	Drug: chemotherapy; First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO; Other Names: mtx for low risk; Other: Follow up; the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.; Other Names: not chemotherapy immediately

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemotherapy cycles	the efficacy and number of treatment cycles in the chemotherapy group	120 months
hCG declined to normal spontaneously of group B	the spontaneous regression rate in Group B	120 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung nodules	the changes of lung nodules	240 months
follow up of group A , B and C	the proportion of spontaneous regression in the follow-up groups, progression-free survival (PFS) and overall survival (OS) in the chemotherapy group	240 months

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Qilu Hospital of Shandong University; First Affiliated Hospital of Wenzhou Medical University; Tianjin Central Hospital of Gynecology Obstetrics; The First People's Hospital of Yunnan; Zhejiang Provincial Tongde Hospital; Huzhou Maternity and Child Health Care Hospital; Tongji Hospital Affiliated to Tongji Medical College of HUST; Women and Children's Hospital of Ningbo University; Hangzhou Fuyang Women And Children Hospital; Shaoxing Shangyu Women And Children Hospital
• Investigators: Principal Investigator: Xing Xie, Women's Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2018
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chemotherapy; Pulmonary Nodule; Chorionic Gonadotrophin
• Additional Relevant MeSH Terms: Urogenital Diseases; Neoplasms; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Trophoblastic Neoplasms; Pregnancy Complications, Neoplastic; Gestational Trophoblastic Disease; Hydatidiform Mole; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Pterins; Pteridines; Aminopterin; Methotrexate; Drug Therapy
• Other Study ID Numbers: CSEM 012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No