Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer.

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

this is a randomized controlled trial aims to compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate).

Researchers will compare Arm A: patients received EUS-FNI of gemcitabine plus standard systemic chemotherapy to Arm B : patients receiving the standard systemic chemotherapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old.

Patients recently diagnosed to have pancreatic adenocarcinoma based on histopathological examination.

Locally advanced potentially resectable pancreatic cancer . .Eastern Cooperative Oncology Group performance status of 0 to 1. .Signed informed consent.

Disqualifiers

Age < 18 years old.

Metastatic pancreatic cancer.

prior pancreatic surgery or chemotherapy or radiotherapy. concurrent or prior malignancy. coexistent medical condition precluding protocol therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic ultrasonograhy guided chemptherapy injection

    Drug

    endoscopic ultrasonograhy guided chemptherapy injection

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate)

The primary outcome of this study is to compare the progression-free survival between patients with locally advanced pancreatic cancer who receive EUS-guided injection of gemcitabine plus systemic chemotherapy (Arm A) and those who receive standard systemic chemotherapy alone (Arm B). Progression-free survival is defined as the time from randomization to the first documented progression of disease (as per RECIST criteria) or death, whichever occurs first. The secondary outcome will be the comparison of the response rate between the two treatment arms. Objective response rate will be measured as the proportion of patients who achieve either complete response (CR) or partial response (PR) to treatment, according to RECIST criteria. By evaluating both progression-free survival and response rate, the trial aims to determine whether the addition of EUS-guided gemcitabine injection enhances the effectiveness of systemic chemotherapy in treating locally advanced pancreatic cancer

Time frame
every one month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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