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 (Anticipated): 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 (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. pathologic confirmed hydatidiform mole
2. 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
3. the hCG level do not meet FIGO diagnostic criteria of GTN
4. good compliance
5. consent informed

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemotherapy cycles	chemotherapy cycles to achieve hCG normalization and failure to first line	20 month
hCG declined to normal spontaneously of group B	The proportion of patients with hCG level declined to normal spontaneously of group B	20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follow up of lung nodules	the change of the lung nodules during follow up in group B and C	32 month

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• 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 (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2025

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): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Chemotherapy; Pulmonary Nodule; Chorionic Gonadotrophin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Hydatidiform Mole
• 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