Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 60
SponsorWomen's Hospital School Of Medicine Zhejiang University
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed HM.
The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
The patients are willing to compliant with the study protocol and be followed up at regular intervals.
Disqualifiers
The patients with a previous history of lung nodules.
The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
The patients have undergone prophylactic hysterectomy or chemotherapy.
Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Follow up
Other interventionthe follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
chemotherapy
DrugFirst line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: A:chemotherapy immediatelyActive comparator 1 intervention
Group B: B:follow upExperimental treatment 2 interventions
Group C: C: lung nodule diameter <1.0 cmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
chemotherapy cycles
the efficacy and number of treatment cycles in the chemotherapy group
Time frame
120 months2
hCG declined to normal spontaneously of group B
the spontaneous regression rate in Group B
Time frame
120 monthsSecondary outcomes
1
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
Time frame
240 months2
lung nodules
the changes of lung nodules
Time frame
240 monthsSponsors and contacts
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Tongji Hospital Affiliated to Tongji Medical College of HUST
Collaborator
The First People's Hospital of Yunnan
Collaborator
Tianjin Central Hospital of Gynecology Obstetrics
Collaborator
Women and Children's Hospital of Ningbo University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Hangzhou Fuyang Women And Children Hospital
Collaborator
Zhejiang Provincial Tongde Hospital
Collaborator
Shaoxing Shangyu Women And Children Hospital
Collaborator
Huzhou Maternity and Child Health Care Hospital
Collaborator
Source ClinicalTrials.gov