Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

Summary

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Oxaliplatin

85 mg/m2 D1 over 2 hours every; 14 days, 12 cycles, 24 weeks

DRUG

Irinotecan

150 mg/m2 D1 over 90 minutes to begin 30 min after the Folinic acid infusion is started; every 14 days, 12 cycles, 24 weeks

DRUG

Folinic acid

400 mg/m2 (racemic mixture) (or 200 mg/m2 if L-folinic acid is used), IV infusion over 2 hours; every 14 days, 12 cycles, 24 weeks

DRUG

5-fluorouracil

2.4 g/m2 IV continuous infusion over 46 hours (1200 mg/m2/ day); every 14 days, 12 cycles, 24 weeks

DRUG

Gemcitabine

1000mg/m2 is given as an IV infusion over 30 minutes; on day 1, 8 and 15 out of 28 days (= 1 cycle); Repeated 6 times (i.e., 6 cycles) for 24 weeks

DRUG

Capecitabine

1660mg/m2/day in two divided doses administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles i.e. 24 weeks

Sponsors & Collaborators

• Molecular Health GmbH

  collaborator INDUSTRY

• German Cancer Research Center

  collaborator OTHER

• Nationales Centrum für Tumorerkrankungen

  collaborator UNKNOWN

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

  collaborator OTHER

• Institut für Medizinische Biometrie

  collaborator UNKNOWN

• John Neoptolemos

  lead OTHER

Principal Investigators

• John Neoptolemos, Prof. Dr. · Universität Heidelberg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2031-01-01

Completion

2031-09-01

Countries

• Germany
• Sweden

Study Locations