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NCT01535053 · REGISTRY CONDITION SEARCH

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-08-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Complete Response

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outcome · POSTED

Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm

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outcome · POSTED

The Number of Participants With Post Protocol Surgical Treatment for Each Arm.

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outcome · POSTED

The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.

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outcome · POSTED

Patient-reported Quality of Life (QOL) at Baseline

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outcome · POSTED

Patient-reported Quality of Life (QOL) After Baseline Visit.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * 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: * A \< 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (\> 50 mIU/ml minimum) OR * A \> 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (\> 50 mIU/ml minimum) OR * A persistently elevated hCG level a period of 6 months or more following the initial curettage (\> 50 mIU/ml minimum) * Choriocarcinoma * Histologically proven non-metastatic choriocarcinoma OR * Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung * World Health Organization (WHO) risk score 0-6 * Patients must be willing to practice effective contraception for the duration of the study * White blood cell count (WBC) \>= 3,000 cells/mcL * Granulocytes \>= 1,500/mcL * Platelets \>= 100,000/mcL * Creatinine =\< 2.0 mg/dcL * Bilirubin =\< 1.5 x institutional normal * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x institutional normal * Alkaline phosphatase =\< 3 x institutional normal * Patients who have met the pre-entry requirements * Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * Patients who do not have GTN * Patients with non-gestational choriocarcinoma * Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study * Patients who have received prior pelvic radiation * Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) * Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4 * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up * Patients who wish to breast-feed during treatment
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive dactinomycin IV over 15 minutes on day 1.
    intervention Names
    1. Biological: Dactinomycin
    2. Other: Quality-of-Life Assessment
    label
    Arm I (dactinomcin)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Leucovorin Calcium
    2. Drug: Methotrexate
    3. Other: Quality-of-Life Assessment
    label
    Arm II (leucovorin calcium and methotrexate)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (dactinomcin)
    description
    Given IV
    name
    Dactinomycin
    other Names
    1. Actinomycin A IV
    2. Actinomycin C1
    3. Actinomycin D
    4. Actinomycin I1
    5. Actinomycin IV
    6. Actinomycin X 1
    7. Actinomycin-[thr-val-pro-sar-meval]
    8. Cosmegen
    9. DACT
    10. Dactinomycine
    11. Lyovac Cosmegen
    12. Meractinomycin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm II (leucovorin calcium and methotrexate)
    description
    Given PO
    name
    Leucovorin Calcium
    other Names
    1. Adinepar
    2. Calcifolin
    3. Calcium (6S)-Folinate
    4. Calcium Folinate
    5. Calcium Leucovorin
    6. Calfolex
    7. Calinat
    8. Cehafolin
    9. Citofolin
    10. Citrec
    11. Citrovorum Factor
    12. Cromatonbic Folinico
    type
    DRUG
  3. arm Group Labels
    1. Arm II (leucovorin calcium and methotrexate)
    description
    Given IV and IM
    name
    Methotrexate
    other Names
    1. Abitrexate
    2. Alpha-Methopterin
    3. Amethopterin
    4. Brimexate
    5. CL 14377
    6. CL-14377
    7. Emtexate
    8. Emthexat
    9. Emthexate
    10. Farmitrexat
    11. Fauldexato
    12. Folex
    type
    DRUG
  4. arm Group Labels
    1. Arm I (dactinomcin)
    2. Arm II (leucovorin calcium and methotrexate)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
57
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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
    measure
    Percentage of Participants With Complete Response
    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.
secondary Outcomes
  1. description
    Maximum grade of physician assessed adverse events reported during treatment
    measure
    Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
    time Frame
    Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
  2. measure
    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.
  3. measure
    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.
  4. description
    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.
    measure
    Patient-reported Quality of Life (QOL) at Baseline
    time Frame
    Prior to cycle 1
  5. description
    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.
    measure
    Patient-reported Quality of Life (QOL) After Baseline Visit.
    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.
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Schink JC, Filiaci V, Huang HQ, Tidy J, Winter M, Carter J, Anderson N, Moxley K, Yabuno A, Taylor SE, Kushnir C, Horowitz N, Miller DS. An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275. Gynecol Oncol. 2020 Aug;158(2):354-360. doi: 10.1016/j.ygyno.2020.05.013. Epub 2020 May 24.
    pmid
    32460997
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
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    Preserved source evidence · Not medical advice