Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304070
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2006-03-15
Brief Title:
Cisplatin-Based Chemotherapy andor Surgery in Treating Young Patients With Adrenocortical Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy A Groupwide Phase III Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III clinical trial is studying how well cisplatin-based chemotherapy andor 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
Detailed Description:
PRIMARY OBJECTIVES
I Describe the outcome of patients with stage I adrenocortical tumor ACT treated with surgery alone
II Describe the outcome of patients with stage II ACT treated with radical adrenalectomy plus regional retroperitoneal lymph node dissection
III Describe the outcome of patients with unresectable or metastatic ACT treated with mitotane and a cisplatin-based chemotherapy regimen
SECONDARY OBJECTIVES
I Determine the feasibility and complications associated with the use of radical adrenalectomy and regional node dissection RLND in these patients
II Determine the toxicity of mitotane when administered with cisplatin etoposide and doxorubicin hydrochloride in patients with residual disease after surgery inoperable tumors or metastatic disease at diagnosis
III Determine prospectively the frequency of tumor spillage during surgery in these patients
IV Determine the frequency of lymph node involvement in these patients V Compare the incidence and type of germline p53 mutation in non-Brazilian children and children from Southern Brazil
VI Characterize the cooperating molecular alterations associated with ACT VII Determine the presence of embryonal markers in children with ACT
OUTLINE
STRATUM I stage I disease Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation Patients who have undergone prior surgery without nodal sampling undergo observation only
STRATUM II stage II disease Patients undergo 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
STRATUM III stage III or IV disease
INDUCTION CHEMOTHERAPY Patients receive cisplatin-based chemotherapy comprising oral mitotane four times daily on days 1-21 cisplatin IV over 6 hours on days 1-2 etoposide IV over 1 hour on days 1-3 and doxorubicin hydrochloride IV over 1 hour on days 4-5 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 Treatment repeats every 21 days for 2-4 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or partial response proceed to surgery Patients with a complete response proceed directly to continuation chemotherapy
SURGERY Patients with stage III disease undergo extended surgery and regional lymph node dissection Patients with stage IV disease undergo primary tumor resection if feasible with regional lymph node dissection and resection of the metastases Patients then proceed to continuation chemotherapy
CONTINUATION CHEMOTHERAPY Patients receive additional cisplatin-based chemotherapy as in induction chemotherapy for 4-6 courses followed by mitotane alone for an additional 2 months Patients with stage IV disease then proceed to additional surgery when feasible
ADDITIONAL SURGERY Patients with stage IV disease may undergo additional primary tumor resection with regional lymph node dissection and resection or re-resection of the metastases
After completion of study treatment patients are followed periodically for at least 5 years
I Describe the outcome of patients with stage I adrenocortical tumor ACT treated with surgery alone
II Describe the outcome of patients with stage II ACT treated with radical adrenalectomy plus regional retroperitoneal lymph node dissection
III Describe the outcome of patients with unresectable or metastatic ACT treated with mitotane and a cisplatin-based chemotherapy regimen
SECONDARY OBJECTIVES
I Determine the feasibility and complications associated with the use of radical adrenalectomy and regional node dissection RLND in these patients
II Determine the toxicity of mitotane when administered with cisplatin etoposide and doxorubicin hydrochloride in patients with residual disease after surgery inoperable tumors or metastatic disease at diagnosis
III Determine prospectively the frequency of tumor spillage during surgery in these patients
IV Determine the frequency of lymph node involvement in these patients V Compare the incidence and type of germline p53 mutation in non-Brazilian children and children from Southern Brazil
VI Characterize the cooperating molecular alterations associated with ACT VII Determine the presence of embryonal markers in children with ACT
OUTLINE
STRATUM I stage I disease Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation Patients who have undergone prior surgery without nodal sampling undergo observation only
STRATUM II stage II disease Patients undergo 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
STRATUM III stage III or IV disease
INDUCTION CHEMOTHERAPY Patients receive cisplatin-based chemotherapy comprising oral mitotane four times daily on days 1-21 cisplatin IV over 6 hours on days 1-2 etoposide IV over 1 hour on days 1-3 and doxorubicin hydrochloride IV over 1 hour on days 4-5 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 Treatment repeats every 21 days for 2-4 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or partial response proceed to surgery Patients with a complete response proceed directly to continuation chemotherapy
SURGERY Patients with stage III disease undergo extended surgery and regional lymph node dissection Patients with stage IV disease undergo primary tumor resection if feasible with regional lymph node dissection and resection of the metastases Patients then proceed to continuation chemotherapy
CONTINUATION CHEMOTHERAPY Patients receive additional cisplatin-based chemotherapy as in induction chemotherapy for 4-6 courses followed by mitotane alone for an additional 2 months Patients with stage IV disease then proceed to additional surgery when feasible
ADDITIONAL SURGERY Patients with stage IV disease may undergo additional primary tumor resection with regional lymph node dissection and resection or re-resection of the metastases
After completion of study treatment patients are followed periodically for at least 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00413 | REGISTRY | None | None |
| COG-ARAR0332 | None | None | None |
| ARAR0332 | None | None | None |
| CDR0000467191 | None | None | None |
| ARAR0332 | OTHER | None | None |
| ARAR0332 | OTHER | None | None |
| U10CA180886 | NIH | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |