Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

Pancreas Cancer Clinical Trial

— SPARTA  

Official title:

Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043857
• Other study ID #: 2957
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: July 2025

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: Marta Scorsetti, Prof
• Phone: +390282248523
• Email: marta.scorsetti[@]hunimed.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiotherapy (SBRT)
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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence Rate	local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT	1 year
Secondary	disease-free interval	disease-free interval in operated pancreatic cancer patients following adjuvant SBRT	1 year
Secondary	Overall Survival	Overall Survival in operated pancreatic cancer patients following adjuvant SBRT	1 year