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

Sponsor
Ding Ma (Other)
Overall Status
Unknown status
CT.gov ID
NCT01823315
Collaborator
Zhejiang University (Other), Huazhong University of Science and Technology (Other), Shandong University (Other)
300
3
3
84
100
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MTX 1
  • Drug: MTX 2
  • Biological: Act-d
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Experimental: 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.

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)

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

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Complete response (CR) by single-course [through study completion, an average of 1 year]

  2. Completely remission rate by multiple courses after single-course failure [through study completion, an average of 1 year]

Secondary Outcome Measures

  1. remission rate of ACTD replacement after MTX resistance [through study completion, an average of 1 year]

  2. the number of courses needed to achieve complete remission after multi-course treatment [through study completion, an average of 1 year]

  3. complete remission rate by multidrug combination therapy after single drug failure [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030
2 Qilu Hospital,Shandong University Jinan Shandong China 250012
3 Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310006

Sponsors and Collaborators

  • Ding Ma
  • Zhejiang University
  • Huazhong University of Science and Technology
  • Shandong University

Investigators

  • Study Chair: Xing Xie, MD, PhD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01823315
Other Study ID Numbers:
  • 2012-GYN/GTN-01
First Posted:
Apr 4, 2013
Last Update Posted:
Dec 24, 2019
Last Verified:
Dec 1, 2019

Study Results

No Results Posted as of Dec 24, 2019