NCT02172976

Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer

Completed Phase 2/Phase 3 Last updated 1 September 2020

What this trial tests

Phase 2/Phase 3 trial testing Gemcitabine in Resectable Prancreas Carcinoma in 40 participants. Completed in 1 May 2020.

Timeline

1 November 2014

Primary endpoint
1 January 2020

1 May 2020

Quick facts

Lead sponsor	Krankenhaus Nordwest
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 November 2014
Primary completion	1 January 2020
Estimated completion	1 May 2020
Sites	1 location across Germany

Drugs / interventions tested

• Gemcitabine (gemcitabine) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• 5-Fluorouracil
• Irinotecan (irinotecan) — full drug profile →
• Natriumfolinate — full drug profile →

Conditions studied

• Resectable Prancreas Carcinoma — all drugs for Resectable Prancreas Carcinoma →

Sponsor

Krankenhaus Nordwest — full company profile →

Who can join

Adults 18 to 75, any sex, with Resectable Prancreas Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• median overall survival
  Time frame: From date of randomization until the date of death from any cause assessed up to 24 months

Sponsor's own description

In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX.

The overall survival between both therapies will be compared as well as other parameters.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pancreatic Ductal Adenocarcinoma: Current and Evolving Therapies.
   Adamska A, Domenichini A, Falasca M. · · 2017 · cited 429× · PMID 28640192 · DOI 10.3390/ijms18071338
2. Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
   Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
3. Neoadjuvant Treatment in Pancreatic Cancer.
   Oba A, Ho F, Bao QR, Al-Musawi MH, et al · · 2020 · cited 156× · PMID 32185128 · DOI 10.3389/fonc.2020.00245
4. An update on treatment options for pancreatic adenocarcinoma.
   Lambert A, Schwarz L, Borbath I, Henry A, et al · · 2019 · cited 155× · PMID 31598142 · DOI 10.1177/1758835919875568
5. Neoadjuvant Treatment in Patients With Resectable and Borderline Resectable Pancreatic Cancer.
   Janssen QP, O'Reilly EM, van Eijck CHJ, Groot Koerkamp B. · · 2020 · cited 67× · PMID 32083002 · DOI 10.3389/fonc.2020.00041
6. Contemporary Management of Localized Resectable Pancreatic Cancer.
   Kommalapati A, Tella SH, Goyal G, Ma WW, et al · · 2018 · cited 59× · PMID 29361690 · DOI 10.3390/cancers10010024
7. Metastatic pancreatic cancer: Is there a light at the end of the tunnel?
   Vaccaro V, Sperduti I, Vari S, Bria E, et al · · 2015 · cited 49× · PMID 25944992 · DOI 10.3748/wjg.v21.i16.4788
8. Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group.
   Ettrich TJ, Berger AW, Perkhofer L, Daum S, et al · · 2018 · cited 42× · PMID 30594153 · DOI 10.1186/s12885-018-5183-y