Clinical trial · Interventional
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adjuvant Stereotactic Pancreatic Radiotherapy
- description
- Postoperative Stereotactic Body Radiation Therapy (SBRT) after pancreatic tumor resection. 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.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Local Recurrence Rate
- timeFrame
- 1 year
- description
- local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMassaro M, Comito T, Franzese C, Teriaca MA, Loi M, Badalamenti M, Franceschini D, Ilieva MB, Marini B, Lo Faro L, Vernier V, Tomatis S, Gallo P, Bozzarelli S, Rimassa L, Bonifacio C, Carrara S, Capretti GL, Santoro A, Zerbi A, Scorsetti M. Adjuvant stereotactic pancreatic radiotherapy (SPARTA trial): interim safety analysis of an ongoing phase II single center prospective study. Radiat Oncol. 2026 May 13;21(1):84. doi: 10.1186/s13014-026-02848-3. PMID 42129843