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Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

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ClinicalTrials.gov Identifier: NCT00304070
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage I Adrenocortical Carcinoma Stage II Adrenocortical Carcinoma Stage III Adrenocortical Carcinoma Stage IV Adrenocortical Carcinoma Drug: doxorubicin hydrochloride Procedure: conventional surgery Drug: cisplatin Drug: mitotane Drug: etoposide Biological: filgrastim Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study
Study Start Date : September 2006
Actual Primary Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stratum I (surgery, observation)
Patients undergo conventional surgery (primary tumor resection and retroperitoneal lymph node sampling) followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.
 Procedure: conventional surgery
Patients undergo surgery
Other Name: surgery, conventional
Experimental: Stratum II (exploratory surgery, observation)
Patients undergo conventional surgery (primary tumor resection and extended regional lymph node dissection) followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.
 Procedure: conventional surgery
Patients undergo surgery
Other Name: surgery, conventional
Experimental: Stratum III (chemotherapy, surgery)
Patients receive combination chemotherapy with a total of 8 cycles of chemotherapy with cisplatin, etoposide and doxorubicin hydrochloride, filgrastim (G-CSF). The first 2 to 4 cycles are called the induction phase, followed by mitotane alone for an additional 2 months. Some patients undergo conventional surgery after chemotherapy course 2 or 4. Some patients undergo additional conventional surgery after finishing all chemotherapy.
 Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF

Procedure: conventional surgery
Patients undergo surgery
Other Name: surgery, conventional

Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

Drug: mitotane
Given orally
Other Names:
  • DDD
  • Lysodren
  • o,p'-DDD

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213

Biological: filgrastim
Given subcutaneously
Other Names:
  • G-CSF
  • Neupogen


Outcome Measures
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Primary Outcome Measures :
  1. Five Year Event-free Survival (EFS) [ Time Frame: Up to five years after enrollment ]
    The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.


Secondary Outcome Measures :
  1. Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 182 Days After Enrollment ]
    The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy

  2. Complications Associated With Radical Adrenalectomy and RLND [ Time Frame: Up to 1 month after surgery ]
    Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.

  3. Frequency of Lymph Node Involvement by Imaging. [ Time Frame: At study enrollment ]
    The number eligible patients who have lymph node involvement by imaging at study enrollment.

  4. Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis. [ Time Frame: At study enrollment ]
    The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.

  5. Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin. [ Time Frame: Patients who had surgery at time of enrollment. ]
    The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.

  6. Frequency of Tumor Spillage at the Time of Tumor Resection [ Time Frame: Up to one year or while on protocol therapy, whichever is less ]
    The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304070


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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carlos Rodriguez-Galindo Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00304070     History of Changes
Other Study ID Numbers: ARAR0332
NCI-2009-00413 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000467191
COG-ARAR0332
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2006    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
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Carcinoma
Adrenocortical Carcinoma
Adrenal Cortex Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Cisplatin
Doxorubicin
 Liposomal doxorubicin
Etoposide
Etoposide phosphate
Mitotane
Lenograstim
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs