Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer (Net-Pac)

CHIR-Net

Status and phase: Terminated; Phase 3

Conditions: Pancreatic Adenocarcinoma

Treatments: Procedure: Surgery; Radiation: neoadjuvant RTx

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01419002

NetPac

Details and patient eligibility

About

Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Full description

The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the pancreatic head
• Age ≥ 18 years
• Signed informed consent
• ECOG performance status of 0-2

Exclusion criteria

• Curative resection is not feasible or presence of metastatic disease
• Patients not eligible for surgery (ASA ≥ 4)
• Participation in an other clinical trial
• Unable or unwilling to sign the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Neoadjuvant RTx

Experimental group

Treatment:

Radiation: neoadjuvant RTx

Surgery

Active Comparator group

Treatment:

Procedure: Surgery