Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

NCT03822936 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: CNAO 35/2017 C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

Conditions

Cancer of Pancreas; Pancreas Adenocarcinoma; Resectable Pancreatic Cancer

Keywords

carbon ion radiation therapy; exocrine pancreas; pancreas tumour

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  The local progression free survival is measured

  The local progression free survival will be assessed at 1-year

Secondary Outcomes (4)

• overall survival

  The overall survival of enrolled patients will be assessed at 2-years

• resectability rate R0 stratified (operable vs not operable)

  time of surgery (4-6 weeks after radiotherapy)

• Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

  The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year.

• intra and perioperatory complications

  The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days

Study Arms (1)

Preoperatory chemoradiation therapy with carbon ions

EXPERIMENTAL

Chemoradiation followed by surgery

Drug: Preoperative chemotherapy; Radiation: Preoperative radiotherapy

Interventions

Preoperative chemotherapy DRUG

Preoperative chemotherapy, carbon ion therapy, surgery

Also known as: Folinic acid, Irinotecan, fluorouracil, oxaliplatin

Preoperatory chemoradiation therapy with carbon ions

Preoperative radiotherapy RADIATION

Preoperative chemotherapy, carbon ion therapy, surgery

Also known as: Carbon ion therapy

Preoperatory chemoradiation therapy with carbon ions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologic/cytologic diagnosis of exocrine pancreas tumour
• resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
• no metastasis from US, CT, PET, MRI or laparotomy
• Karnofsky index \>= 70
• stomach and duodenum not infiltrated by tumour
• given informed consent to study procedures
• Hb \> 9 g/dL, N\> 1500, PLT\> 100000
• creatininemia \< 1.5 mg/dL; bilirubinemia \< 1.5 times upper normal values; albumin \> 3 g/dL
• DPD normal activity
• contraception required and breast feeding not permitted

You may not qualify if:

• non resectable, locally advanced tumours
• insular cells tumour
• comorbidities excluding abdominal surgery and/or chemo- radiation therapy
• known metastasis
• DPD low activity
• inability to attend study procedures and follow ups
• pregnancy
• previous diagnosis of other tumour with more disadvantageous prognosis then the study object
• metallic biliary stent
• metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
• clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
• medical and/or psychical condition preventing from radiation therapy
• past radiation therapy on abdomen.

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

CNAO

Pavia, Pavia, 27100, Italy

Location

Related Publications (2)

• Barcellini A, Molinelli S, Vanoli A, Vitolo V, Fossati P, Vai A, Pagani A, Inzani F, Pecorilla M, Butturini G, Klersy C, Preda L, Facoetti A, Valvo F, Orlandi E. Preoperative chemo-CIRT in Re/BRe pancreatic cancer: Insights from a multicenter prospective phase II clinical study (NCT03822936). Tumori. 2024 Dec;110(6):470-474. doi: 10.1177/03008916241291341. Epub 2024 Oct 27.

  PMID: 39462835 DERIVED

• Vitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0.

  PMID: 31521134 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Leucovorin; Irinotecan; Fluorouracil; Oxaliplatin; Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Radiotherapy; Therapeutics

Study Officials

• Francesca Valvo, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: February 8, 2018
• Primary Completion: August 8, 2022
• Study Completion: February 10, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)