Intensified treatment in patients with oligometastatic pancreatic cancer - multimodal surgical treatment versus systemic chemotherapy alone: a randomized controlled trial - METAPANC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsmedizin Goettingen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

13 Oct 2023 → ongoing

Decision date (initial)

2025-04-09

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Deutsche Forschungsgemeinschaft (DFG)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Is the overall survival in patients with oligometastatics pancreatic cancer superior in patients treated with perioperative mFOLFIRINOX-followed by complete surgical resection compared to standard-of-care mFOLFIRINOX first-line chemotherapy alone.

Secondary objectives 4

1. Development of image-based biomarkers for therapy response prediction and disease outcome
2. Identification of biomarkers for better identification of a potential target population which may benefit from intensified multimodal treatment strategies
3. Identification of Biomarkers (e.g. molecular, radiological) associated with progression or resistance to study treatment
4. Identification of Biomarkers adding to the understanding of Pancreatic ductal adenocarcinoma tumor biology

Conditions and MedDRA coding

oligometastatic pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 18 years and ≤ 80 years
2. histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
3. medical and technical operability of the primary tumor
4. limited synchronous liver metastatic status (≤3 resectable/ablatively treatable liver metastases) OR limited metachronous liver metastatic status (≤3 resectable/ ablatively treatable liver metastases), but must have completed adjuvant chemotherapy at least 6 months before start of study treatment
5. Previous neo-/adjuvant anti-cancer therapy for non-metastatic PDAC with last dose administered ≥6 months before the start of study treatment are allowed
6. adequate hematological (WBC ≥3000/µl, platelets ≥100.000/µl, hemoglobin ≥8 g/dl), hepatic (bilirubin ≤2.5 x mg/dl) and renal function (creatinine clearance >50 ml/min) parameters
7. ECOG performance status ≤1
8. Written informed consent obtained according to international guidelines and local laws
9. measurable disease according to RECIST v1.1. prior to induction therapy

Exclusion criteria 11

1. Unresectable pancreatic cancer
2. Prior chemotherapy within 6 months or prior radiation therapy within 28 days (e.g. in adjuvant settings). Exception for previous systemic anti-cancer treatment for metastatic PDAC: Patients with need of immediate treatment (high tumour load, symptoms) may have received one cycle of FOLFIRINOX or modified FOLFIRINOX prior to study entry (Cycle 0) and may be enrolled after Coordinating Investigator approval has been obtained.
3. Concurrent malignancy other than the disease under investigation with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible
4. Patients with either peritoneal carcinomatosis or >3 liver metastases or extrahepatic metastasis)
5. Known hypersensitivity to the active substances or any of the excipients
6. Impaired cardiac function or clinically significant cardio-vascular disease, such as: – Congestive heart failure requiring treatment (NYHA grade >2), or clinically significant arrhythmia (including uncontrolled atrial flutter/fibrillation) – Acute myocardial infarction, unstable angina pectoris, coronary stenting, or bypass surgery < 3 months prior to study entry
7. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
8. Inability to understand the study and/or comply with the protocol procedures
9. Subject pregnant or breast feeding, or planning to become pregnant within 6 months
10. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
11. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS): Time from randomization to death from any cause or EOS

Secondary endpoints 5

1. Progression-free survival (PFS): Time of randomization to cancer progression or death or EOS
2. Procedure related complications and mortality
3. Quality of life (EORTC QLQ-C30, PAN-26, CIPN20)
4. Quality-adjusted Time without Symptoms and Toxicity (Q-TWIST) Assessment of safety
5. General safety of surgical removal of tumor and metastases in patients with oligometastatic pancreatic cancer

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsmedizin Goettingen

Sponsor organisation

Universitaetsmedizin Goettingen

Address

Robert-Koch-Strasse 40, Weende Weende

City

Goettingen

Postcode

37075

Country

Germany

Scientific contact point

Organisation

Universitaetsmedizin Goettingen

Contact name

Clinical Trials Unit

Public contact point

Organisation

Universitaetsmedizin Goettingen

Contact name

Clinical Trials Unit

Locations

4 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications