Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Women's Hospital School Of Medicine Zhejiang University

Status: Enrolling

Conditions: Gestational Trophoblastic Neoplasia; Hydatidiform Mole

Treatments: Other: Follow up; Drug: chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03785574

CSEM 012

Details and patient eligibility

About

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

Full 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)

Enrollment: 30 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

A:chemotherapy immediately

Active Comparator group

Description:

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

Treatment:

Drug: chemotherapy

B:follow up

Experimental group

Description:

B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.

Treatment:

Drug: chemotherapy

Other: Follow up

C: lung nodule diameter <1.0 cm

Experimental group

Description:

C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.

Treatment:

Drug: chemotherapy

Other: Follow up