Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-24

Study Completion Date

2030-09-01

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

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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)

Conditions

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Hydatidiform Mole Gestational Trophoblastic Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A:chemotherapy immediately

Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

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.

Group Type EXPERIMENTAL

Follow up

Intervention Type OTHER

the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.

chemotherapy

Intervention Type DRUG

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

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.

Group Type EXPERIMENTAL

Follow up

Intervention Type OTHER

the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.

chemotherapy

Intervention Type DRUG

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Interventions

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Follow up

the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.

Intervention Type OTHER

chemotherapy

First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Intervention Type DRUG

Other Intervention Names

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not chemotherapy immediately mtx for low risk

Eligibility Criteria

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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.

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No