NCT05043857Active, not recruiting
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Sept 2021
- Start date
- 6 Jul 2021
- Primary completion date
- 31 May 2026
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Pancreatic cancer
- NCT number
- NCT05043857
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 6 Jul 2021 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Metastatic disease
- History of malignancies except for non-melanoma cutaneous tumors
Other
- Biliary tract or neuroendocrine neuroplasm
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.