Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

NCT05043857 | Active Not Recruiting

• 1 other identifier: 2957
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Local Recurrence Rate

  local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT

  1 year

Secondary Outcomes (2)

• disease-free interval

  1 year

• Overall Survival

  1 year

Study Arms (1)

Adjuvant Stereotactic Pancreatic Radiotherapy

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

Postoperative Stereotactic Body Radiation Therapy (SBRT) after tumor resection targeting 2 volumes * CTV1 (clips+isotropic 5mm expansion, edited on anatomic barriers): receiving 40 Gy in 5 fractions of 8 Gy * CTV2 (CTV1+ anisotropic 10-15 mm expansion including corresponding vessels, retroperitoneum posterior to the SMV/SMA or celiac axis, edited on anatomic barriers): receiving 30 Gy in 5 fractions of 6 Gy.

Adjuvant Stereotactic Pancreatic Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Varian Medical Systems: collaborator
• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, MI, 20089, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 14, 2021
• Study Start: July 6, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)