NCT03251365

Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

Status unknown Phase 2, PHASE3 Last updated 16 August 2017

What this trial tests

Phase 2, PHASE3 trial testing HIPEC-gemcitabine in Resectable Pancreatic Adenocarcinoma in 42 participants. Status unknown.

Timeline

27 July 2017

Primary endpoint
31 December 2020

31 December 2024

Quick facts

Lead sponsor	Hospital General de Ciudad Real
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	27 July 2017
Primary completion	31 December 2020
Estimated completion	31 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• HIPEC-gemcitabine — full drug profile →

Conditions studied

• Resectable Pancreatic Adenocarcinoma — all drugs for Resectable Pancreatic Adenocarcinoma →

Sponsor

Hospital General de Ciudad Real

Who can join

18 and older, any sex, with Resectable Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the incorporation of other centers that would increase the power of the obtained results . Our hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer, and decreasing the recurrence of the disease

Publications & conference data

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

1. Immunotherapy, Radiotherapy, and Hyperthermia: A Combined Therapeutic Approach in Pancreatic Cancer Treatment.
   Mahmood J, Shukla HD, Soman S, Samanta S, et al · · 2018 · cited 43× · PMID 30486519 · DOI 10.3390/cancers10120469
2. A comprehensive analysis of clinical trials in pancreatic cancer: what is coming down the pike?
   Katayama ES, Hue JJ, Bajor DL, Ocuin LM, et al · · 2020 · cited 39× · PMID 33014285 · DOI 10.18632/oncotarget.27727
3. Chemotherapy and radiotherapy for advanced pancreatic cancer.
   Haggstrom L, Chan WY, Nagrial A, Chantrill LA, et al · · 2024 · cited 12× · PMID 39635901 · DOI 10.1002/14651858.cd011044.pub3
4. Therapeutic Status and Available Strategies in Pancreatic Ductal Adenocarcinoma.
   Thakur G, Kumar R, Kim SB, Lee SY, et al · · 2021 · cited 9× · PMID 33670230 · DOI 10.3390/biomedicines9020178
5. Advances and Challenges in Cancer Stem Cells for Onco-Therapeutics.
   Alnasser SM. · · 2023 · cited 8× · PMID 38094260 · DOI 10.1155/2023/8722803
6. Place of hyperthermic intraperitoneal chemotherapy in the armament against pancreatic adenocarcinoma: A survival, mortality and morbidity systematic review.
   Larentzakis A, Anagnostou E, Georgiou K, Vrakopoulou GZ, et al · · 2021 · cited 6× · PMID 33664810 · DOI 10.3892/ol.2021.12507
7. Are Aspects of Integrative Concepts Helpful to Improve Pancreatic Cancer Therapy?
   Oei SL, Schad F. · · 2023 · cited 5× · PMID 36831465 · DOI 10.3390/cancers15041116
8. Efficacy and safety of intraperitoneal chemotherapy for pancreatic cancer.
   Safari D, Fakhrolmobasheri M, Soleymanjahi S. · · 2024 · cited 2× · PMID 39367354 · DOI 10.1186/s12893-024-02526-9