Clinical trial NCT05043857: Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
Official title: Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2021-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically \<25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.

Detailed description: Pancreatic carcinoma is expected to become in the next 10 years the second leading cause of cancer-related mortality. Resection is the only treatment with the potential to achieve long-term survival, although expected survival at 5 year is \<25%: postoperative use of local and systemic adjuvant treatments has been proposed to improve outcome While the efficacy of adjuvant chemotherapy, in parrticular multiagent chemotherapy, has been established, the potential impact of chemoradiation in the adjuvant setting is still controversial. However, its use in patients with high risk features such as nodal involvement and close or positive margins may be of interest.

Adjuvant chemoradiation, when clinically indicated, is usually delivered in a 6 week treatment course in association with concurrent dose-adapted chemotherapy, implying the necessity to interrupt more effective multi-agent chemotherapy schedules due to risk of increased toxicity.

It has been proposed that higher radiotherapy doses may result in improved outcome although a potential detrimental effect on survival of dose escalation \>55 Gy with conventional fractionation, possibly related to increased toxicity, has been reported. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course. In a retrospective study by Rwigema et al, adjuvant pancreatic SBRT was shown to be a safe and feasible treatment option for patients with high-risk pancreatic adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

* Surgically treated T1-T4 adenocarcinoma with or without prior chemotherapy AND close (\<2.5mm)/positive resection margin AND/OR N1 staging at lymphadenectomy
* ECOG performance status \<2
* Age \> 18
* Estimated life expectancy \> 6 months
* Ability to provide written informed consent
* Cardiovascular comorbidities limiting life expectancy

Exclusion Criteria:

* Metastatic disease
* Biliary tract or neuroendocrine neuroplasm
* History of malignancies except for non-melanoma cutaneous tumors

Primary outcomes:
measure: Local Recurrence Rate
timeFrame: 1 year
Secondary outcomes:
measure: disease-free interval
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: MI
Study officials:
References: