Gestational Trophoblastic Neoplasia, Hydatidiform Mole
Conditions
Keywords
Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin
Brief summary
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
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)
Interventions
OTHERFollow up
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
DRUGchemotherapy
First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Qilu Hospital of Shandong University
Tongji Hospital Affiliated to Tongji Medical College of HUST
The First People's Hospital of Yunnan
Tianjin Central Hospital of Gynecology Obstetrics
Women and Children's Hospital of Ningbo University
First Affiliated Hospital of Wenzhou Medical University
Hangzhou Fuyang Women And Children Hospital
Zhejiang Provincial Tongde Hospital
Shaoxing Shangyu Women And Children Hospital
Huzhou Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy cycles | 120 months | the efficacy and number of treatment cycles in the chemotherapy group |
| hCG declined to normal spontaneously of group B | 120 months | the spontaneous regression rate in Group B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| follow up of group A , B and C | 240 months | the proportion of spontaneous regression in the follow-up groups, progression-free survival (PFS) and overall survival (OS) in the chemotherapy group |
| lung nodules | 240 months | the changes of lung nodules |
Countries
China
Contacts
CONTACTXiao Li, dortor
PRINCIPAL_INVESTIGATORXing Xie
Women's Hospital, Zhejiang University School of Medicine
Outcome results
None listed