Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Women's Hospital School Of Medicine Zhejiang University30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hydatidiform Mole Gestational Trophoblastic Neoplasia

Eligibility

Sex: FEMALEMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

chemotherapy cycles

the efficacy and number of treatment cycles in the chemotherapy group

Time frame: 120 months

hCG declined to normal spontaneously of group B

the spontaneous regression rate in Group B

Time frame: 120 months

Secondary Outcomes

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 months

lung nodules

the changes of lung nodules