Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Not Applicable

Recruiting

• Conditions: Hydatidiform Mole; Gestational Trophoblastic Neoplasia
• Interventions: Drug: chemotherapy; Other: Follow up

• Registration Number: NCT03785574
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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

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 Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-21
• Study Start: 2018-12-24
• Study First Posted: 2018-12-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A:chemotherapy immediately	chemotherapy	Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
B:follow up	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.
B:follow up	chemotherapy	B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.
C: lung nodule diameter <1.0 cm	Follow up	C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.
C: lung nodule diameter <1.0 cm	chemotherapy	C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.

Primary Outcome Measures

Name	Time	Method
chemotherapy cycles	120 month	the efficacy and number of treatment cycles in the chemotherapy group
hCG declined to normal spontaneously of group B	120	the spontaneous regression rate in Group B

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Weiguo Lv; 🇨🇳 Hangzhou, Zhejiang, China