Under 21, any sex, with Stage I Adrenal Cortical Carcinoma AJCC v7 or Stage II Adrenal Cortical Carcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Five Year Event-free Survival (EFS)Primary· 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.
Group
Value
95% CI
Stratum 1
0.86
0.62 – 0.95
Stratum 2
0.53
0.26 – 0.74
Stratum 3
0.51
0.33 – 0.66
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0Secondary· 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
Incidence of Abdominal Infection
Group
Value
95% CI
Stratum 3
1
Incidence of Abdominal Pain
Group
Value
95% CI
Stratum 3
2
Incidence of Acidosis
Group
Value
95% CI
Stratum 3
1
Activated Partial Thromboplastin Time Prolonged
Group
Value
95% CI
Stratum 3
1
Incidence of Adrenal Insufficiency
Group
Value
95% CI
Stratum 3
5
Incidence of Alanine Aminotransferase Increased
Group
Value
95% CI
Stratum 3
2
Incidence of Allergic Reaction
Group
Value
95% CI
Stratum 3
1
Incidence of Anemia
Group
Value
95% CI
Stratum 3
22
Complications Associated With Radical Adrenalectomy and RLNDSecondary· 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.
Group
Value
95% CI
All Patients
1
Frequency of Lymph Node Involvement by Imaging.Secondary· At study enrollment
The number eligible patients who have lymph node involvement by imaging at study enrollment.
Group
Value
95% CI
All Patients
71
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.Secondary· 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.
C229R mutation in p53 in Patients from Brazil
Group
Value
95% CI
All Patients
0
C229R mutation in Patients not from Brazil
Group
Value
95% CI
All Patients
2
E180K mutation in p53 in Patients from Brazil
Group
Value
95% CI
All Patients
0
E180K mutation in Patients not from Brazil
Group
Value
95% CI
All Patients
1
G245C mutation in p53 in Patients from Brazil
Group
Value
95% CI
All Patients
0
G245C mutation in Patients not from Brazil
Group
Value
95% CI
All Patients
1
I254T mutation in p53 in Patients from Brazil
Group
Value
95% CI
All Patients
1
I254T mutation in Patients not from Brazil
Group
Value
95% CI
All Patients
0
Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.Secondary· Patients who had surgery at time of enrollment.
The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.
children with ACT - wild type (beta)-catenin
Group
Value
95% CI
All Patients
51
A43 del33bp mutation of (beta)-catenin
Group
Value
95% CI
All Patients
1
Frequency of Tumor Spillage at the Time of Tumor ResectionSecondary· 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.
Group
Value
95% CI
All Patients
15
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07195734 — Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
· Phase 2
· recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
· Phase 2
· not yet recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
Other Children's Oncology Group trials
Trials by the same sponsor.
NCT07412002 — Quality of End-of-Life Care for Children With Cancer
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NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant
· Phase 1
· withdrawn
NCT07022678 — Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
· Phase 3
· not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk
· Phase 2, PHASE3
· not yet recruiting
NCT06858501 — Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Oncology Group
Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00304070.