Phase 3
N=78
Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
Stage I Adrenal Cortical Carcinoma AJCC v7 · Stage II Adrenal Cortical Carcinoma AJCC v7 · Stage III Adrenal Cortical Carcinoma AJCC v7 · Stage IV Adrenal Cortical Carcinoma AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT00304070 ↗Enrolled (actual)
78
Serious AEs
2.6%
Results posted
Jun 2017
Primary outcome: Primary: Five Year Event-free Survival (EFS) — 0.86; 0.53; 0.51 Estimated probability five year EFS — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cisplatin (Drug); Conventional Surgery (Procedure); Doxorubicin Hydrochloride (Drug); Etoposide (Drug); Filgrastim (Biological); Mitotane (Drug); Pegfilgrastim (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five Year Event-free Survival (EFS) |
0.86; 0.53; 0.51 | 0.44 |
| SECONDARY Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
1; 2; 1; 1; 5; 2 | — |
| SECONDARY Complications Associated With Radical Adrenalectomy and RLND |
1 | — |
| SECONDARY Frequency of Lymph Node Involvement by Imaging. |
71 | — |
| SECONDARY 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. |
0; 2; 0; 1; 0; 1 | — |
| SECONDARY Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin. |
51; 1 | — |
| SECONDARY Frequency of Tumor Spillage at the Time of Tumor Resection |
15 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00304070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.