Addition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasability (LAPC-1)

Phase 2

Completed

• Conditions: locally advanced pancreatic carcinoma; Pancreatic cancer; 10015674; 10017991

• Registration Number: NL-OMON44466
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

- Cytological or Histologically confirmed pancreatic cancer.
- WHO performance status of 0 or 1
- ASA classification I or II
- Tumor considered locally advanced after diagnostic work-up including CT-imaging
and diagnostic laparoscopy.
- No evidence of metastatic disease
- Largest tumor diameter < 7 cm x 7 cm x 7 cm
- Normal renal function (Creatinine * 30 ml/min).
- Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
- Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and
hemoglobin > 5.6 mmol/l)
- Age > 18 years and < 75 years
- Written informed consent

Exclusion Criteria

- Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
- Lymph node metastases from primary tumor outside the field of radiation.
- Second primary malignancy except in situ carcinoma of the cervix, adequately treated
non-melanoma skin cancer, or other malignancy treated at least 3 years previously
without evidence of recurrence.
- Pregnancy, breast feeding.
- Serious concomitant systemic disorders that would compromise the safety of the
patient or his/her ability to complete the study, at the discretion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints are defined as overall survival (OS), time to progression<br /><br>(TTP) and toxicity of stereotactic radiotherapy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are: radiological response, resectability and progression<br /><br>(local as well as distant)</p><br>