Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

NCT ID: NCT01823315

Last Updated: 2019-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2019-12-31

Brief Summary

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.

Conditions

Gestational Trophoblastic Disease; Gestational Trophoblastic Neoplasia; Gestational Trophoblastic Tumor; Gestational Trophoblastic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methotrexate Single-coure chemotherapy

Regimen: Methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5. If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen.

Group Type: EXPERIMENTAL

MTX 1

Intervention Type: DRUG

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

Methotrexate+dactinomycin Single-dose chemotherapy

Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, >4h).

If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen.

Group Type: EXPERIMENTAL

MTX 2

Intervention Type: DRUG

MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, \>4h)

Act-d

Intervention Type: BIOLOGICAL

Act-d 0.6mg/m(2), IV, on day1,2

MTX multiple courses chemotherapy

Regimen: methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5, 2-week intervals. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive at least 1 additional consolidation treatment.

After treatment, all the patients were asked for contraception with condom or oral contraception. Regular hCG surveillance, once a month for 3 consecutive months and once every 3 months for 2 years, was performed. During follow-up period, pelvic ultrasound and pulmonary X ray or CT scan were conducted if needed.

Group Type: ACTIVE_COMPARATOR

MTX 1

Intervention Type: DRUG

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

Interventions

MTX 1

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

Intervention Type: DRUG

MTX 2

MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, \>4h)

Intervention Type: DRUG

Act-d

Act-d 0.6mg/m(2), IV, on day1,2

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);
• WHO risk score 0-6;
• Age≤60 years; female, Chinese women;
• Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;
• Performance status: Karnofsky score≥60;
• Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
• Provide written informed consent.

Exclusion Criteria

• Patients with unconfirmed diagnosis of GTN;
• Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
• WHO risk score >6;
• With severe or uncontrolled internal disease, unable to receive chemotherapy;
• Concurrently participating in other clinical trials
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: collaborator

Ding Ma

OTHER

Sponsor Role: lead

Responsible Party

Ding Ma

Director of the department of Obstetrics and Gynecology, Tongji Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xing Xie, MD, PhD

Role: STUDY_CHAIR

Zhejiang University

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Qilu Hospital，Shandong University

Jinan, Shandong, China

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2012-GYN/GTN-01

Identifier Type: -

Identifier Source: org_study_id