Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Hydatidiform Mole, Gestational Trophoblastic Neoplasia

Intervention / Treatment
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* Other: Follow up
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A:chemotherapy immediately<br>Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO | Drug: chemotherapy<br>* First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO<br>* Other names: mtx for low risk;|
| Experimental: B:follow up<br>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<br>* the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.<br>* Other names: not chemotherapy immediately;Drug: chemotherapy<br>* First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO<br>* Other names: mtx for low risk;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin