Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-11
Brief Title:
Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase 1b2 Trial Using Neoadjuvant Lurbinectedin With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas of Extremity Trunk and Retroperitoneum
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 is a multi-center multi-arm open-label phase IbII clinical study assessing the efficacy of concurrent lurbinectedin in combination with radiotherapy in patients with locally advanced resectable high-grade sarcomas
Detailed Description:
PRIMARY OBJECTIVES
Phase Ib
I To determine the safety and tolerability of neoadjuvant lurbinectedin
in combination with preoperative 2 weeks of hypofractionated radiation for extremity and trunk sarcoma or
with 6 weeks of conventionally fractionated radiation for retroperitoneal sarcoma II To determine the maximum tolerated dose MTD for neoadjuvant lurbinectedin in combination with preoperative external beam radiation therapy EBRT in patients with sarcoma
Phase II
I To estimate the efficacy of neoadjuvant lurbinectedin in combination with preoperative EBRT hypofractionated or conventionally fractionated according to endpoint defined by sarcoma type and location
Cohort 1 extremity and trunk sarcoma HFRT
Cohort 2 Extremity myxoid liposarcoma HFRT
Cohort 3 Retroperitoneal sarcoma CFRT course
SECONDARY OBJECTIVES
I Time to disease progression local or distant recurrence
II Overall response rate ORR pre-operative as measured by RECIST 11 or a later tool for monitoring disease progression
III Overall survival
IV To grade radiation related skin toxicity overlying the tumor area
V To determine long term major wound healing complications with the use of this combination in all cohorts
EXPLORATORY OBJECTIVES
I To evaluate changes in monocyte macrophage T cell and RNA expression levels over time
OUTLINE
Participants will receive neoadjuvant lurbinectedin concurrent with radiation therapy Non-investigational surgery will be performed 4-6 weeks from the end of radiation therapy Participants with localized disease at the time of study enrollment will be on surveillance on-study for 2 years Post-operatively participants will be followed every 12 - 4 weeks for approximately 2 years from the end of treatment Participants with known metastatic disease will be followed until progression toxicity and thereafter for 2 years
Phase Ib
I To determine the safety and tolerability of neoadjuvant lurbinectedin
in combination with preoperative 2 weeks of hypofractionated radiation for extremity and trunk sarcoma or
with 6 weeks of conventionally fractionated radiation for retroperitoneal sarcoma II To determine the maximum tolerated dose MTD for neoadjuvant lurbinectedin in combination with preoperative external beam radiation therapy EBRT in patients with sarcoma
Phase II
I To estimate the efficacy of neoadjuvant lurbinectedin in combination with preoperative EBRT hypofractionated or conventionally fractionated according to endpoint defined by sarcoma type and location
Cohort 1 extremity and trunk sarcoma HFRT
Cohort 2 Extremity myxoid liposarcoma HFRT
Cohort 3 Retroperitoneal sarcoma CFRT course
SECONDARY OBJECTIVES
I Time to disease progression local or distant recurrence
II Overall response rate ORR pre-operative as measured by RECIST 11 or a later tool for monitoring disease progression
III Overall survival
IV To grade radiation related skin toxicity overlying the tumor area
V To determine long term major wound healing complications with the use of this combination in all cohorts
EXPLORATORY OBJECTIVES
I To evaluate changes in monocyte macrophage T cell and RNA expression levels over time
OUTLINE
Participants will receive neoadjuvant lurbinectedin concurrent with radiation therapy Non-investigational surgery will be performed 4-6 weeks from the end of radiation therapy Participants with localized disease at the time of study enrollment will be on surveillance on-study for 2 years Post-operatively participants will be followed every 12 - 4 weeks for approximately 2 years from the end of treatment Participants with known metastatic disease will be followed until progression toxicity and thereafter for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2024-00107 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |