Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272162
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-08
Brief Title:
Locally Advanced Pancreatic Cancer After Systemic Therapy Ablative MR-guided Radiotherapy
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Locally Advanced Pancreatic Cancer After Systemic Therapy Ablative MR-guided Radiotherapy a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
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:
LAPSTAR
Brief Summary:
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy MRgRT after systemic therapy with current standard treatment alone on health-related quality of life in patients with locally advanced pancreatic cancer LAPC
Detailed Description:
Rationale About 40 of patients with pancreatic cancer are diagnosed with locally advanced pancreatic cancer LAPC Recommended treatment consists of chemotherapy to prevent disease dissemination and prolong survival Nevertheless local tumor growth often causes severe morbidity including pain gastrointestinal obstruction and malnutrition This has a substantial negative impact on health-related quality of life HRQoL Eventually one-third of patients die due to local tumor growth rather than from systemic disease spread For palliation of symptoms and improved local tumor control potentially prolonging survival minimally-invasive ablative therapies may be effective Online adaptive stereotactic Magnetic Resonance-guided radiotherapy MRgRT is an innovative treatment modality that enables high-precision ablative radiotherapy for pancreatic tumors This potentially improves RT efficacy without increasing the risk of RT-related toxicity Consequently MRgRT holds promise for the treatment of pancreatic cancer
Objective To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free survival including death as an event in patients with LAPC after systemic chemotherapy
Study design Nationwide randomized controlled trial 11 randomization
Study population Patients with LAPC according to Dutch Pancreatic Cancer Group DPCG criteria who are not eligible for tumor resection after at least two months of chemotherapy sample size 150 patients Also patients with LAPC who are eligible but choose to refrain from chemotherapy andor surgery can participate in this trial
Intervention Patients in the intervention arm receive 50Gy MRgRT in five fractions over two weeks in one of the four Consortium Centers followed by standard care either consisting of continuation of chemotherapy or best supportive care Patients in the control arm continue standard care without ablative MRgRT
Main study endpoints The primary outcome is HRQoL deterioration-free survival from the time of randomization defined as the Time Until Definitive Deterioration TUDD including death as an event HRQoL is evaluated using the EORTC QLQ-C30 Summary Score The TUDD is defined as a 10-point minimal clinically important difference compared to baseline with no further improvement of 10 points afterwards All patients will be offered home monitoring using the Trialhome platform to decrease the burden of trial participation
Objective To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free survival including death as an event in patients with LAPC after systemic chemotherapy
Study design Nationwide randomized controlled trial 11 randomization
Study population Patients with LAPC according to Dutch Pancreatic Cancer Group DPCG criteria who are not eligible for tumor resection after at least two months of chemotherapy sample size 150 patients Also patients with LAPC who are eligible but choose to refrain from chemotherapy andor surgery can participate in this trial
Intervention Patients in the intervention arm receive 50Gy MRgRT in five fractions over two weeks in one of the four Consortium Centers followed by standard care either consisting of continuation of chemotherapy or best supportive care Patients in the control arm continue standard care without ablative MRgRT
Main study endpoints The primary outcome is HRQoL deterioration-free survival from the time of randomization defined as the Time Until Definitive Deterioration TUDD including death as an event HRQoL is evaluated using the EORTC QLQ-C30 Summary Score The TUDD is defined as a 10-point minimal clinically important difference compared to baseline with no further improvement of 10 points afterwards All patients will be offered home monitoring using the Trialhome platform to decrease the burden of trial participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 15030 | OTHER_GRANT | None | None |
| 23U-0725 | OTHER | NedMec | None |