Clinical trial
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study
Name
ARAR0332
Description
This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
Trial arms
Trial start
2007-05-03
Estimated PCD
2015-12-31
Trial end
2023-06-30
Status
Completed
Phase
Early phase I
Treatment
Cisplatin
Given IV
Arms:
Stratum III (chemotherapy, surgery)
Other names:
Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Conventional Surgery
Patients undergo surgery
Arms:
Stratum I (surgery, observation), Stratum II (exploratory surgery, observation), Stratum III (chemotherapy, surgery)
Doxorubicin Hydrochloride
Given IV
Arms:
Stratum III (chemotherapy, surgery)
Other names:
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
Etoposide
Given IV
Arms:
Stratum III (chemotherapy, surgery)
Other names:
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16
Filgrastim
Given subcutaneously
Arms:
Stratum III (chemotherapy, surgery)
Other names:
Filgrastim-aafi, Filgrastim-ayow, G-CSF, Neupogen, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tevagrastim
Mitotane
Given orally
Arms:
Stratum III (chemotherapy, surgery)
Other names:
(o,p)-DDD, 1, 1-Dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl)ethane, 1-Chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]benzene, 2, 2-Bis(2-chlorophenyl-4-chlorophenyl)-1,1-dichloroethane, 2, 4'-Dichlorodiphenyldichloroethane, CB 313, CB-313, Chloditan, Chlodithane, DDD, Ethane, 2-(o-chlorophenyl)-2-(p-chlorophenyl)-1,1-dichloro-, Khloditan, Lisodren, Lysodren, Mytotan, o,p' - DDD, o,p'-DDD, Ortho,para-DDD, WR-13045
Pegfilgrastim
Given subcutaneously
Arms:
Stratum III (chemotherapy, surgery)
Other names:
Filgrastim SD-01, filgrastim-SD/01, Fulphila, HSP-130, Jinyouli, Neulasta, Neulastim, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, Pegfilgrastim-jmdb, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo
Size
78
Primary endpoint
Five Year Event-free Survival (EFS)
Up to five years after enrollment
Eligibility criteria
Inclusion Criteria:
* Histologically confirmed adrenocortical carcinoma
* Newly diagnosed disease within the past 3 weeks
* Any disease stage allowed
* Lansky performance status 60-100% (for patients ≤ 16 years old)
* Karnofsky performance status 60-100% (for patients \> 16 years old)
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
* 0.4 mg/dL (1 month to \< 6 months)
* 0.5 mg/dL (6 months to \< 1 year of age)
* 0.6 mg/dL (1 to \< 2 years of age
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No previous chemotherapy for adrenocortical carcinoma
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 78, 'type': 'ACTUAL'}}
Updated at
2024-02-28
1 organization
Organization
Children's Oncology Group