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Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00304070
First received: March 15, 2006
Last updated: May 11, 2017
Last verified: November 2016
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- 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:
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
| Enrollment: | 78 |
| Study Start Date: | September 2006 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Procedure: conventional surgery
Patients undergo surgery
Other Name: surgery, conventional
Drug: cisplatin
Given IV
Other Names:
Drug: mitotane
Given orally
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: filgrastim
Given subcutaneously
Other Names:
|
Show Detailed Description
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00304070
Show 80 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304070
Show 80 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Carlos Rodriguez-Galindo | Children's Oncology Group |
More Information
| 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 ) |
| Study First Received: | March 15, 2006 |
| Results First Received: | October 21, 2016 |
| Last Updated: | May 11, 2017 |
Additional relevant MeSH terms:
|
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 Liposomal doxorubicin Etoposide phosphate |
Cisplatin Doxorubicin Etoposide 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 |
ClinicalTrials.gov processed this record on September 21, 2017