Trial · NCT00304070

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

NCT00304070, Phase 3, Completed, Children's Oncology Group; results first posted 2017-06-12

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor. Trials, record NCT00304070. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00304070

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
NCT number: NCT00304070
Status: Completed
Phases: Phase 3
Enrollment: 78 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: 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
Interventions: Cisplatin, Conventional Surgery, Doxorubicin Hydrochloride, Etoposide, Filgrastim, Mitotane, Pegfilgrastim
First posted: 2006-03-17
Last updated: 2024-02-28
Results first posted: 2017-06-12

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Five Year Event-free Survival (EFS)	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	Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	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
Secondary	Complications Associated With Radical Adrenalectomy and RLND	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.
Secondary	Frequency of Lymph Node Involvement by Imaging.	At study enrollment	The number eligible patients who have lymph node involvement by imaging at study enrollment.
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.	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.
Secondary	Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.	Patients who had surgery at time of enrollment.	The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.
Secondary	Frequency of Tumor Spillage at the Time of Tumor Resection	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Five Year Event-free Survival (EFS)	Up to five years after enrollment		Estimated probability five year EFS	NUMBER
SECONDARY	Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Up to 182 Days After Enrollment		participants	NUMBER
SECONDARY	Complications Associated With Radical Adrenalectomy and RLND	Up to 1 month after surgery	Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.	participants	NUMBER
SECONDARY	Frequency of Lymph Node Involvement by Imaging.	At study enrollment	Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement	Participants	COUNT_OF_PARTICIPANTS
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.	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 (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)	participants	NUMBER
SECONDARY	Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.	Patients who had surgery at time of enrollment.	Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Frequency of Tumor Spillage at the Time of Tumor Resection	Up to one year or while on protocol therapy, whichever is less		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group111

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Five Year Event-free Survival (EFS)	Stratum 1		0.86	95% Confidence Interval 0.62 to 0.95	Estimated probability five year EFS
Five Year Event-free Survival (EFS)	Stratum 2		0.53	95% Confidence Interval 0.26 to 0.74	Estimated probability five year EFS
Five Year Event-free Survival (EFS)	Stratum 3		0.51	95% Confidence Interval 0.33 to 0.66	Estimated probability five year EFS
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Abdominal Infection	1		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Abdominal Pain	2		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Acidosis	1		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Activated Partial Thromboplastin Time Prolonged	1		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Adrenal Insufficiency	5		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Alanine Aminotransferase Increased	2		participants
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stratum 3	Incidence of Allergic Reaction	1		participants

1 to 10 of 111Source ClinicalTrials.gov

See all 111 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1	24
Overall Study	STARTED	Stratum 2	15
Overall Study	STARTED	Stratum 3	39
Overall Study	COMPLETED	Stratum 1	21
Overall Study	COMPLETED	Stratum 2	8
Overall Study	COMPLETED	Stratum 3	27
Overall Study	NOT COMPLETED	Stratum 1	3
Overall Study	NOT COMPLETED	Stratum 2	7
Overall Study	NOT COMPLETED	Stratum 3	12

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal infection	Infections and infestations	Stratum 3	1	39	1
other	Abdominal pain	Gastrointestinal disorders	Stratum 3	2	39	2
other	Acidosis	Metabolism and nutrition disorders	Stratum 3	1	39	1
other	Activated partial thromboplastin time prolonged	Investigations	Stratum 3	1	39	1
other	Adrenal insufficiency	Endocrine disorders	Stratum 3	5	39	5
other	Agitation	Psychiatric disorders	Stratum 3	1	39	1
other	Alanine aminotransferase increased	Investigations	Stratum 3	3	39	3
other	Allergic reaction	Immune system disorders	Stratum 3	1	39	1
other	Alopecia	Skin and subcutaneous tissue disorders	Stratum 3	1	39	1
other	Anemia	Blood and lymphatic system disorders	Stratum 3	24	39	24

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum 3
Total, other adverse events	Stratum 3	38	39
Total, serious adverse events	Stratum 3	1	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34675114	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00304070

GET https://conductscience.org/api/trials/v1/NCT00304070/results?page=2

API reference For AI assistants