Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03067181




Registration number
NCT03067181
Ethics application status
Date submitted
14/02/2017
Date registered
1/03/2017
Date last updated
7/06/2024

Titles & IDs
Public title
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Scientific title
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors
Secondary ID [1] 0 0
NCI-2017-00178
Secondary ID [2] 0 0
AGCT1531
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Extracranial Germ Cell Tumor 0 0
Extragonadal Embryonal Carcinoma 0 0
Germ Cell Tumor 0 0
Malignant Germ Cell Tumor 0 0
Malignant Ovarian Teratoma 0 0
Stage I Ovarian Choriocarcinoma 0 0
Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7 0 0
Stage I Ovarian Teratoma AJCC v6 and v7 0 0
Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7 0 0
Stage I Testicular Choriocarcinoma AJCC v6 and v7 0 0
Stage I Testicular Embryonal Carcinoma AJCC v6 and v7 0 0
Stage I Testicular Seminoma AJCC v6 and v7 0 0
Stage I Testicular Yolk Sac Tumor AJCC v6 and v7 0 0
Stage II Ovarian Choriocarcinoma 0 0
Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7 0 0
Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7 0 0
Stage II Testicular Choriocarcinoma AJCC v6 and v7 0 0
Stage II Testicular Embryonal Carcinoma AJCC v6 and v7 0 0
Stage II Testicular Yolk Sac Tumor AJCC v6 and v7 0 0
Stage III Ovarian Choriocarcinoma 0 0
Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7 0 0
Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7 0 0
Stage III Testicular Choriocarcinoma AJCC v6 and v7 0 0
Stage III Testicular Embryonal Carcinoma AJCC v6 and v7 0 0
Stage III Testicular Yolk Sac Tumor AJCC v6 and v7 0 0
Stage IV Ovarian Choriocarcinoma 0 0
Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7 0 0
Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7 0 0
Testicular Mixed Choriocarcinoma and Embryonal Carcinoma 0 0
Testicular Mixed Choriocarcinoma and Teratoma 0 0
Testicular Mixed Choriocarcinoma and Yolk Sac Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Best Practice
Treatment: Surgery - Biopsy
Treatment: Surgery - Biospecimen Collection
Other interventions - Bleomycin Sulfate
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Surgery - Computed Tomography
Treatment: Drugs - Etoposide
Treatment: Surgery - Magnetic Resonance Imaging
Other interventions - Pharmacogenomic Study
Treatment: Surgery - Pulmonary Function Test
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration

Experimental: Arm I (bleomycin, carboplatin, etoposide) - Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

Experimental: Arm II (bleomycin, etoposide, cisplatin) - Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

Experimental: Arm III (bleomycin, etoposide, carboplatin) - Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

Experimental: Arm IV (bleomycin, etoposide, cisplatin) - Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

Experimental: Low-Risk (observation) - Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.


Other interventions: Best Practice
Undergo observation

Treatment: Surgery: Biopsy
Undergo a tumor biopsy

Treatment: Surgery: Biospecimen Collection
Undergo blood sample collection

Other interventions: Bleomycin Sulfate
Given IV

Treatment: Drugs: Carboplatin
Given IV

Treatment: Drugs: Cisplatin
Given IV

Treatment: Surgery: Computed Tomography
Undergo a CT scan

Treatment: Drugs: Etoposide
Given IV

Treatment: Surgery: Magnetic Resonance Imaging
Undergo MRI

Other interventions: Pharmacogenomic Study
Correlative studies

Treatment: Surgery: Pulmonary Function Test
Undergo a pulmonary function test

Other interventions: Quality-of-Life Assessment
Ancillary studies

Other interventions: Questionnaire Administration
Ancillary studies
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Two years post enrollment
Primary outcome [2] 0 0
Event-free survival
Timepoint [2] 0 0
Two years post enrollment
Secondary outcome [1] 0 0
Proportion of participants with hearing loss
Timepoint [1] 0 0
8 weeks after the last dose of platin therapy
Secondary outcome [2] 0 0
Number of participants by understanding score category in the Adolescents and Young Adults-Hearing Screen
Timepoint [2] 0 0
Baseline

Eligibility
Key inclusion criteria
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and
stage I non-seminoma or seminoma malignant GCT [all sites])

- Standard risk 1: Patients must be < 11 years of age at enrollment

- Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment

- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I
germ cell tumor; for the standard risk arms, patients must be newly diagnosed with
metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary
extracranial germ cell tumor in any of the categories outlined below is required of
all patients at enrollment except for those who were initially diagnosed with stage I
non-seminoma malignant GCT and later recur during observation post surgery off study;
for these patients, if elevated tumor markers rise to > 5 x upper limit of normal
(ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is
not required for enrollment

- Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology
Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB;
grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk
sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT);
tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages

- Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage:
COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC)
testicular stage IA, IB and IS; histology: must contain at least one of the following:
yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages

- Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular
stage IA IB, and IS; histology: may contain immature/mature teratoma; may NOT contain
yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages

- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage
II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus
Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of
the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) <
11

- Standard risk 2 (SR2)

- Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology:
must contain at least one of the following: yolk sac tumor, embryonal carcinoma,
or choriocarcinoma; age (years) >= 11 and < 25

- Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk;
histology: must contain at least one of the following: yolk sac tumor, embryonal
carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op:
alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) <
3.0 x normal; age (years) >= 11 and < 25

- Site: extragonadal; stage: COG stage II; histology: must contain at least one of
the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age
(years) >= 11 and < 25

- Notes:

- IGCCC criteria only apply to SR2 patients with a testicular primary tumor

- Use post-op tumor marker levels to determine IGCCC risk group

- Stage 1 seminoma patients are not eligible for the standard risk arms of the
study

- For the low risk stage I non-seminoma MGCT and the standard risk arms, components
of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with
other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac
tumor is the only malignant component present, then it must be deemed by the
pathologist to be greater than a "microscopic component" of yolk sac tumor

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age

- Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1
and SR2 patients)

- Adequate renal function defined as:

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 (within 7 days prior to enrollment) OR

- A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
(mg/dL)

- 1 month to < 6 months male: 0.4 female: 0.4

- 6 months to < 1 year male: 0.5 female: 0.5

- 1 to < 2 years male: 0.6 female: 0.6

- 2 to < 6 years male: 0.8 female: 0.8

- 6 to < 10 years male: 1 female: 1

- 10 to < 13 years male: 1.2 female: 1.2

- 13 to < 16 years: male: 1.5 female: 1.4

- >= 16 years male: 1.7 female: 1.4

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to
enrollment)

- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT
is 45 U/L) (within 7 days prior to enrollment)

- Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to
enrollment) AND

- Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)

- Patients enrolling on the standard risk arms must be medically fit to receive protocol
treatment and with no contraindications to protocol treatment

- Eligibility criteria to participate in the pilot study of the AYA-Hears instrument
(patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will
not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be
enrolled on the AGCT1531 SR2 arm in order to participate

- >= 11 and < 25 years old at enrollment

- Able to fluently speak and read English

- Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy
including diagnoses other than germ cell tumor

- Followed for cancer or survivorship care at one of the following institutions:

- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

- Dana Farber/Harvard Cancer Center

- Hospital for Sick Children

- Children's Hospital of Eastern Ontario

- Oregon Health and Science University

- Seattle Children's Hospital

- Yale University
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with any diagnoses not listed including:

- Stage I testicular cancer patients who have undergone primary RPLND
(retroperitoneal lymph node dissection)

- Pure dysgerminoma

- Pure mature teratoma

- Pure immature teratoma COG stage I, grade I

- Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >=
1000 ng/mL

- Pure immature teratoma COG stage II - IV or FIGO stage IC to IV

- "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or
IV EG, or IGCCC intermediate or poor risk testicular), or

- Primary central nervous system (CNS) germ cell tumor

- Germ cell tumor with somatic malignant transformation

- Spermatocytic seminoma

- Patients must have had no prior systemic therapy for the current cancer diagnosis

- Patients must have had no prior radiation therapy with the exception of CNS
irradiation of brain metastases; (this exception only applies to SR1 patients; any
patients over age 11 with distant metastases to brain [stage IV disease] would be
considered poor risk and therefore not eligible for this trial)

- Patients with significant, pre-existing co-morbid respiratory disease that
contraindicate the use of bleomycin are ineligible for the standard risk arms of the
trial

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs; a pregnancy test is required for female
patients of childbearing potential; (this criteria applies ONLY to patients who will
receive chemotherapy [SR1 and SR2 patients])

- Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to
patients who will receive chemotherapy [SR1 and SR2 patients])

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation; (this
criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2
patients])

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
2097
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [5] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [8] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Alaska
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Arizona
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United States of America
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Mexico
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North Carolina
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Vermont
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Manitoba
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Quebec
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India
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Mumbai
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Japan
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Aoba-ku
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Chuo-ku
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Japan
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Fukuoka
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Japan
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Hyogo
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Ibaraki
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Kanagawa
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Saitama
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Tokyo
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Hiroshima City
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Japan
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Kyoto
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Nishinomiya, Hyogo
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Japan
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Osaka City
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Puerto Rico
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Caguas
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Puerto Rico
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San Juan
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Saudi Arabia
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Riyadh
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United Kingdom
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England
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United Kingdom
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Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial studies how well active surveillance help doctors to monitor subjects
with low risk germ cell tumors for recurrence after their tumor is removed. When the germ
cell tumor has spread outside of the organ in which it developed, it is considered
metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and
cisplatin, 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. The trial studies
whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic
standard risk germ cell tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03067181
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A. L Frazier
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03067181