Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00304070
First received: March 15, 2006
Last updated: August 5, 2014
Last verified: August 2014
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Mitotane
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
TBO-Filgrastim
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Event-free survival (EFS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]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 mitotane using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Weekly for up to 4 weeks ] [ Designated as safety issue: Yes ]
- Toxicity Associated with Chemotherapy using NCI CTCAE v. 4.0 [ Time Frame: Assessed up to 182 days ] [ Designated as safety issue: No ]
- Feasibility and Complications Associated with Radical Adrenalectomy and RLND [ Time Frame: Up to 1 month after surgery ] [ Designated as safety issue: Yes ]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 will be estimated as the proportion of evaluable patients that have a complication.
- Frequency of Tumor Spillage and Lymph Node Involvement [ Time Frame: At upfront surgery ] [ Designated as safety issue: No ]The percent of patients who have tumor spillage, and the associated 95% confidence interval, will be the indices of this outcome. Similar considerations apply for the determination of the proportion of patients with lymph node involvement.
- 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 baseline ] [ Designated as safety issue: No ]The proportion of patients in each subpopulation will be compared using the exact conditional test of proportions of size 0.05. The power of 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. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
| Enrollment: | 78 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | September 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 |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00304070
Show 80 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Principal Investigator: | Carlos Rodriguez-Galindo | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00304070 History of Changes |
| Other Study ID Numbers: | ARAR0332, NCI-2009-00413, CDR0000467191, COG-ARAR0332, U10CA098543 |
| Study First Received: | March 15, 2006 |
| Last Updated: | August 5, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adrenal Cortex Neoplasms Adrenocortical Carcinoma Carcinoma Adenocarcinoma Adrenal Cortex Diseases Adrenal Gland Diseases Adrenal Gland Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial |
Cisplatin Doxorubicin Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015