Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089544
Status:
TERMINATED
Last Update Posted:
2018-04-13
First Post:
2004-08-06
Brief Title:
Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm Leg or Body Wall
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Phase II Study of Pre-Operative Radiation Therapy and Thalidomide IND 48832 NSC 66847 for Low Grade Primary Soft Tissue Sarcoma or Pre-Operative MAIDThalidomideRadiation Therapy for HighIntermediate Grade Primary Soft Tissue Sarcoma of the Extremity or Body Wall
Status:
TERMINATED
Status Verified Date:
2018-03
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:
Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as doxorubicin ifosfamide and dacarbazine work in different ways to stop tumor cells from dividing so they stop growing or die Giving thalidomide together with radiation therapy andor chemotherapy before surgery may shrink the tumor so that it can be removed This phase II trial is studying how well giving preoperative before surgery thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma and how well giving thalidomide together with radiation therapy doxorubicin ifosfamide and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm leg chest wall or abdominal wall
Detailed Description:
OBJECTIVES
I Determine the treatment delivery and toxicity of the combination of thalidomide and radiotherapy in patients with low-grade primary soft tissue sarcoma of the extremity or body wall
II Determine the treatment delivery and toxicity of the combination of thalidomide and doxorubicin ifosfamide dacarbazine and radiotherapy in patients with high- or intermediate-grade primary soft tissue sarcoma of the extremity or body wall and compare these results with those of patients treated on RTOG-9514
III Determine the feasibility of using specific tissue and circulating biomarkers of antiangiogenic response in patients treated with these regimens in a multi-institutional setting
IV Determine the quantitative changes and patient variabilities of these biomarkers before during and after therapy with these regimens
V Determine the baseline data sets of biomarkers particularly circulating endothelial cells in patients treated with these regimens
VI Determine the tolerance to long-term post-operative thalidomide in these patients
VII Determine the clinical response to pre-operative therapy in these patients
VIII Correlate local control and disease-free survival with surrogate biological endpoints in patients treated with these regimens
OUTLINE This is a pilot cohort study Patients with high- or intermediate-grade tumors 8 cm in diameter are assigned to cohort A and patients with low-grade tumors 5 cm in diameter are assigned to cohort B
Cohort A Patients receive doxorubicin ifosfamide and dacarbazine IV continuously on days 1-3 22-24 and 43-45 Patients receive filgrastim G-CSF subcutaneously beginning on days 4 25 and 46 and continuing until blood counts recover Patients undergo radiotherapy once daily on days 7-11 14-18 21 28-32 35-39 and 42 Patients receive oral thalidomide once daily on days 7-21 and 26-42 Patients undergo surgical resection between days 84 and 98 Beginning 2 weeks after surgery patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity
Cohort B Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery Patients undergo radiotherapy once daily 5 days a week on weeks 1-5 Patients undergo surgical resection between days 77 and 91 Beginning 2 weeks after surgery patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 44 patients 22 per cohort will be accrued for this study within 17 months
I Determine the treatment delivery and toxicity of the combination of thalidomide and radiotherapy in patients with low-grade primary soft tissue sarcoma of the extremity or body wall
II Determine the treatment delivery and toxicity of the combination of thalidomide and doxorubicin ifosfamide dacarbazine and radiotherapy in patients with high- or intermediate-grade primary soft tissue sarcoma of the extremity or body wall and compare these results with those of patients treated on RTOG-9514
III Determine the feasibility of using specific tissue and circulating biomarkers of antiangiogenic response in patients treated with these regimens in a multi-institutional setting
IV Determine the quantitative changes and patient variabilities of these biomarkers before during and after therapy with these regimens
V Determine the baseline data sets of biomarkers particularly circulating endothelial cells in patients treated with these regimens
VI Determine the tolerance to long-term post-operative thalidomide in these patients
VII Determine the clinical response to pre-operative therapy in these patients
VIII Correlate local control and disease-free survival with surrogate biological endpoints in patients treated with these regimens
OUTLINE This is a pilot cohort study Patients with high- or intermediate-grade tumors 8 cm in diameter are assigned to cohort A and patients with low-grade tumors 5 cm in diameter are assigned to cohort B
Cohort A Patients receive doxorubicin ifosfamide and dacarbazine IV continuously on days 1-3 22-24 and 43-45 Patients receive filgrastim G-CSF subcutaneously beginning on days 4 25 and 46 and continuing until blood counts recover Patients undergo radiotherapy once daily on days 7-11 14-18 21 28-32 35-39 and 42 Patients receive oral thalidomide once daily on days 7-21 and 26-42 Patients undergo surgical resection between days 84 and 98 Beginning 2 weeks after surgery patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity
Cohort B Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery Patients undergo radiotherapy once daily 5 days a week on weeks 1-5 Patients undergo surgical resection between days 77 and 91 Beginning 2 weeks after surgery patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 44 patients 22 per cohort will be accrued for this study within 17 months
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-2012-02588 | REGISTRY | None | None |
| RTOG-0330 | None | None | None |
| CDR0000365499 | None | None | None |
| RTOG-0330 | OTHER | None | None |
| RTOG-0330 | OTHER | None | None |
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |