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Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia (GTN-01)

Primary Purpose

Gestational Trophoblastic Disease, Gestational Trophoblastic Neoplasia, Gestational Trophoblastic Tumor

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MTX 1
MTX 2
Act-d
Sponsored by
Ding Ma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Disease

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Qilu Hospital，Shandong University
  • Women's Hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Methotrexate Single-coure chemotherapy

Methotrexate+dactinomycin Single-dose chemotherapy

MTX multiple courses chemotherapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Complete response (CR) by single-course
Completely remission rate by multiple courses after single-course failure

Secondary Outcome Measures

remission rate of ACTD replacement after MTX resistance
the number of courses needed to achieve complete remission after multi-course treatment
complete remission rate by multidrug combination therapy after single drug failure

Full Information

First Posted
March 21, 2013
Last Updated
December 23, 2019
Sponsor
Ding Ma
Collaborators
Zhejiang University, Huazhong University of Science and Technology, Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT01823315
Brief Title
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Acronym
GTN-01
Official Title
A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ding Ma
Collaborators
Zhejiang University, Huazhong University of Science and Technology, Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Disease, Gestational Trophoblastic Neoplasia, Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate Single-coure chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Methotrexate+dactinomycin Single-dose chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
MTX multiple courses chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MTX 1
Intervention Description
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
Intervention Type
Drug
Intervention Name(s)
MTX 2
Intervention Description
MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)
Intervention Type
Biological
Intervention Name(s)
Act-d
Intervention Description
Act-d 0.6mg/m(2), IV, on day1,2
Primary Outcome Measure Information:
Title
Complete response (CR) by single-course
Time Frame
through study completion, an average of 1 year
Title
Completely remission rate by multiple courses after single-course failure
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
remission rate of ACTD replacement after MTX resistance
Time Frame
through study completion, an average of 1 year
Title
the number of courses needed to achieve complete remission after multi-course treatment
Time Frame
through study completion, an average of 1 year
Title
complete remission rate by multidrug combination therapy after single drug failure
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xing Xie, MD, PhD
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Qilu Hospital，Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Women's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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