A Phase 3 interventional study of Dactinomycin and Leucovorin Calcium in Choriocarcinoma, FIGO Stage I Gestational Trophoblastic Tumor and FIGO Stage II Gestational Trophoblastic Tumor, sponsored by GOG Foundation. Completed at 289 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by GOG Foundation · Phase 3, Interventional, and Treatment
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
PRIMARY OBJECTIVES:
I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.
SECONDARY OBJECTIVES:
I. To describe the frequency of post protocol surgical treatment for each arm. II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.
III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.
IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.
V. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dactinomycin intravenously (IV) over 15 minutes on day 1.
ARM II: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
In both arms, treatment repeats every 14 days for up to 20 courses* in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.
NOTE: * Patients will be treated for three courses after human chorionic gonadotropin (hCG) \< 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (\< 5 mIU/mL), patients will be treated with three additional courses.
15 studies on the registry are indexed under Choriocarcinoma; 4 are open to participants now.
This study's enrollment of 57 is above the median of 42 across 11 interventional studies indexed under Choriocarcinoma.
Browse Choriocarcinoma studies →GOG Foundation is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:
Post molar GTN
For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
Choriocarcinoma
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive dactinomycin IV over 15 minutes on day 1.
Biological: Dactinomycin · Other: Quality-of-Life Assessment
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
Drug: Leucovorin Calcium · Drug: Methotrexate · Other: Quality-of-Life Assessment
Given IV
Also known as: Actinomycin A IV, Actinomycin C1, Actinomycin D, Actinomycin I1, Actinomycin IV, Actinomycin X 1, Actinomycin-[thr-val-pro-sar-meval], Cosmegen, DACT, Dactinomycine, Lyovac Cosmegen, Meractinomycin
Given PO
Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin
Given IV and IM
Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
Ancillary studies
Also known as: Quality of Life Assessment
Percentage of Participants With Complete Response
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
Time frame: 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.
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Maximum grade of physician assessed adverse events reported during treatment
Time frame: Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
Time frame: Anytime during post treatment follow-up for up to 2 years from study entry.
The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
Time frame: Anytime during post treatment follow-up for up to 2 years from study entry.
Patient-reported Quality of Life (QOL) at Baseline
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.
Time frame: Prior to cycle 1
Patient-reported Quality of Life (QOL) After Baseline Visit.
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.
Time frame: 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.
The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.
| Milestone | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Started | 29 | 28 |
| Completed | 28 | 26 |
| Not completed | 1 | 2 |
| Withdrew: Ineligible | 1 | 2 |
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
| percentage of participants | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Percentage of Participants With Complete Response | 78.6 (59.0 to 91.7) | 88.5 (69.8 to 97.6) |
Maximum grade of physician assessed adverse events reported during treatment
| participants | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Grade 1 | 7 | 4 |
| Grade 2 | 14 | 10 |
| Grade 3 | 6 | 10 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
| participants | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| The Number of Participants With Post Protocol Surgical Treatment for Each Arm. | 0 | 0 |
| participants | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm. | 0 | 0 |
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.
| units on a scale | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Patient-reported Quality of Life (QOL) at Baseline | 82.3 ± 2.7 | 81.9 ± 3.3 |
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.
| units on a scale | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Pre-cycle 3 | 78.3 ± 2.3 | 81.6 ± 2.7 |
| Pre-cycle 5 | 75.5 ± 3.3 | 78.9 ± 2.8 |
| Pre-cycle 7 | 85.0 ± 2.7 | 84.5 ± 2.2 |
| 26 weeks | 91.2 ± 2.9 | 90.9 ± 2.9 |
Collected over Through Study Treatment and up to 30 days after discontinuing treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regimen I (Dactinomycin) | 0/29 (0%) | 1/28 (3.6%) | 27/28 (96.4%) |
| Regimen II (Methotrexate) | 0/28 (0%) | 1/26 (3.8%) | 24/26 (92.3%) |
| Event | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| AppendicitisInfections and infestations | 0/28 | 1/26 |
| Psychiatric Disorders - OtherPsychiatric disorders | 1/28 | 0/26 |
| Event | Regimen I (Dactinomycin) | Regimen II (Methotrexate) |
|---|---|---|
| Mucositis OralGastrointestinal disorders | 12/28 | 20/26 |
| NauseaGastrointestinal disorders | 20/28 | 16/26 |
| FatigueGeneral disorders | 18/28 | 15/26 |
| AnemiaBlood and lymphatic system disorders | 13/28 | 15/26 |
| ConstipationGastrointestinal disorders | 12/28 | 11/26 |
| Abdominal PainGastrointestinal disorders | 10/28 | 6/26 |
| VomitingGastrointestinal disorders | 8/28 | 6/26 |
| HeadacheNervous system disorders | 8/28 | 5/26 |
| DiarrheaGastrointestinal disorders | 7/28 | 7/26 |
| Neutrophil Count DecreasedInvestigations | 5/28 | 7/26 |
Eligible and treated patients
| Age, Customized(Participants) | Regimen I (Dactinomycin) | Regimen II (Methotrexate) | Total |
|---|---|---|---|
| 10-19 years | 1 | 1 | 2 |
| 20-29 years | 14 | 11 | 25 |
| 30-39 years | 11 | 11 | 22 |
| 40-49 years | 2 | 3 | 5 |
| Sex: Female, Male(Participants) | Regimen I (Dactinomycin) | Regimen II (Methotrexate) | Total |
|---|---|---|---|
| Female | 28 | 26 | 54 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Regimen I (Dactinomycin) | Regimen II (Methotrexate) | Total |
|---|---|---|---|
| Hispanic or Latino | 26 | 24 | 50 |
| Not Hispanic or Latino | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Regimen I (Dactinomycin) | Regimen II (Methotrexate) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 6 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 1 | 7 |
| White | 16 | 19 | 35 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Showing the first 100 of 289 sites across 5 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2012 to primary completion in May 2018, 71 months.
Results were first posted in Aug 2019, 1 year 2 months after primary completion.
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Studies of the drug tested here: Dactinomycin
GOG Foundation