RecruitingNot ApplicableNCT04894643

Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer


Sponsor

EBG MedAustron GmbH

Enrollment

10 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether proton beam radiation combined with chemotherapy (nab-paclitaxel and gemcitabine) given before surgery can make borderline resectable pancreatic cancer operable — meaning cancer that is technically possible to remove but risky due to its location near major blood vessels. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of pancreatic cancer - Your tumor is classified as 'borderline resectable' (near blood vessels but not definitively unremovable) - There is no evidence of distant spread (no metastases) - You have adequate blood counts, liver function, and kidney function - Your performance status is good (Karnofsky index ≥70) - You have not had prior treatment for pancreatic cancer **You may NOT be eligible if...** - Your tumor is a non-exocrine type (like neuroendocrine) - Your cancer has spread to other parts of the body - You have already had abdominal radiation - You are allergic to paclitaxel, gemcitabine, or albumin - You have severe neuropathy (nerve damage) at baseline - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONProton Ions

According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.

DRUGNab-PACLitaxel

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy. It will be administered as intra venous infusion over 30 minutes.

DRUGGemcitabine

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy. Gemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel.

DRUGCapecitabine

Concomitant to proton-radiotherapy (on the same days, within week 14-19)

PROCEDURESurgical resection of the pancreas (when feasible)

Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.


Locations(2)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, Austria

Department of Surgery, LK Wiener Neustadt

Wiener Neustadt, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04894643


Related Trials