Trial · NCT01535053
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
NCT01535053, Phase 3, Completed, GOG Foundation; results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia. Trials, record NCT01535053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01535053
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
- NCT number
- NCT01535053
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- GOG Foundation
- Conditions
- Choriocarcinoma, FIGO Stage I Gestational Trophoblastic Tumor, FIGO Stage II Gestational Trophoblastic Tumor, FIGO Stage III Gestational Trophoblastic Tumor, Hydatidiform Mole
- Interventions
- Dactinomycin, Leucovorin Calcium, Methotrexate, Quality-of-Life Assessment
- First posted
- 2012-02-17
- Last updated
- 2022-08-12
- Results first posted
- 2019-08-13
- Limitations and caveats
- Early closure leading to non-compliance and small numbers of subjects analyzed. Study cannot be considered terminated because some participants are still being examined for follow-up.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response | hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment. | Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml |
| Secondary | Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment | Maximum grade of physician assessed adverse events reported during treatment |
| Secondary | The Number of Participants With Post Protocol Surgical Treatment for Each Arm. | Anytime during post treatment follow-up for up to 2 years from study entry. | |
| Secondary | The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm. | Anytime during post treatment follow-up for up to 2 years from study entry. | |
| Secondary | Patient-reported Quality of Life (QOL) at Baseline | Prior to cycle 1 | Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL. |
| Secondary | Patient-reported Quality of Life (QOL) After Baseline Visit. | Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment. | Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response | hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment. | Eligible patients | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment | Eligible and treated patients | participants | NUMBER |
| SECONDARY | The Number of Participants With Post Protocol Surgical Treatment for Each Arm. | Anytime during post treatment follow-up for up to 2 years from study entry. | Non-responding eligible patients in follow-up | participants | NUMBER |
| SECONDARY | The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm. | Anytime during post treatment follow-up for up to 2 years from study entry. | Non-responding eligible patients in follow-up | participants | NUMBER |
| SECONDARY | Patient-reported Quality of Life (QOL) at Baseline | Prior to cycle 1 | Provided baseline QOL questionnaire | units on a scale | MEAN |
| SECONDARY | Patient-reported Quality of Life (QOL) After Baseline Visit. | Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment. | Provided baseline and ≥1 follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response | Regimen I (Dactinomycin) | 78.6 | 95% Confidence Interval 59.0 to 91.7 | percentage of participants | |
| Percentage of Participants With Complete Response | Regimen II (Methotrexate) | 88.5 | 95% Confidence Interval 69.8 to 97.6 | percentage of participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen I (Dactinomycin) | Grade 1 | 7 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen II (Methotrexate) | Grade 1 | 4 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen I (Dactinomycin) | Grade 2 | 14 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen II (Methotrexate) | Grade 2 | 10 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen I (Dactinomycin) | Grade 3 | 6 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen II (Methotrexate) | Grade 3 | 10 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen I (Dactinomycin) | Grade 4 | 0 | participants | |
| Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm | Regimen II (Methotrexate) | Grade 4 | 0 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen I (Dactinomycin) | 29 | |
| Overall Study | STARTED | Regimen II (Methotrexate) | 28 | |
| Overall Study | COMPLETED | Regimen I (Dactinomycin) | 28 | |
| Overall Study | COMPLETED | Regimen II (Methotrexate) | 26 | |
| Overall Study | NOT COMPLETED | Regimen I (Dactinomycin) | 1 | |
| Overall Study | NOT COMPLETED | Regimen II (Methotrexate) | 2 |
Source ClinicalTrials.gov
Adverse events248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymph Node Pain | Blood and lymphatic system disorders | Regimen I (Dactinomycin) | 0 | 28 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Regimen II (Methotrexate) | 1 | 26 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Regimen I (Dactinomycin) | 1 | 28 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Regimen II (Methotrexate) | 3 | 26 | |
| other | Anemia | Blood and lymphatic system disorders | Regimen I (Dactinomycin) | 13 | 28 | |
| other | Anemia | Blood and lymphatic system disorders | Regimen II (Methotrexate) | 15 | 26 | |
| other | Palpitations | Cardiac disorders | Regimen I (Dactinomycin) | 1 | 28 | |
| other | Palpitations | Cardiac disorders | Regimen II (Methotrexate) | 1 | 26 | |
| other | Cardiac Disorders - Other | Cardiac disorders | Regimen I (Dactinomycin) | 0 | 28 | |
| other | Cardiac Disorders - Other | Cardiac disorders | Regimen II (Methotrexate) | 1 | 26 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen I (Dactinomycin) | 0 | 29 |
| Total, all-cause mortality | Regimen II (Methotrexate) | 0 | 28 |
| Total, other adverse events | Regimen I (Dactinomycin) | 27 | 28 |
| Total, other adverse events | Regimen II (Methotrexate) | 24 | 26 |
| Total, serious adverse events | Regimen I (Dactinomycin) | 1 | 28 |
| Total, serious adverse events | Regimen II (Methotrexate) | 1 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32460997 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regimen I (Dactinomycin) vs Regimen II (Methotrexate): The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm. | Trial comparisons |
| Regimen I (Dactinomycin) vs Regimen II (Methotrexate): The Number of Participants With Post Protocol Surgical Treatment for Each Arm. | Trial comparisons |
| Regimen I (Dactinomycin) vs Regimen II (Methotrexate): deaths from any cause | Trial comparisons |
| Regimen I (Dactinomycin) vs Regimen II (Methotrexate): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01535053/results?page=2