Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer

Pancreatic Cancer Clinical Trial

— CHAMP  

Official title:

Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03724994
• Other study ID #: CHAMP
• Status: Recruiting
• Start date: October 30, 2018
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: Lund University
• Contact: Karin Jirström, Professor
• Phone: +46 46 2220829
• Email: karin.jirstrom[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that started Sept 1 2018. Patients diagnosed with pancreatic or other periampullary adenocarcinoma undergoing adjuvant och palliative chemotherapy are invited to participate. The study will examine the tumors' molecular dynamics and how this may change over time and with treatment. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life. We estimate that 90 patients will be included in the study per year.

Description:

The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate. The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and

2. patients who are unable to receive chemotherapy will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form.

The treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö.

Exclusion Criteria:

1. patients having another concomitant life-threatening disease and

2. patients who are unable to receive chemotherapy.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Periampullary Adenocarcinoma
• Periampullary Cancer

Intervention

Drug:
• Gemcitabine
Adjuvant or palliative chemotherapy according to national guidelines

Locations

Country	Name	City	State
Sweden	Department of Oncology, Skåne University Hospital	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

Andersson G, Borgquist S, Jirstrom K. Hormonal factors and pancreatic cancer risk in women: The Malmo Diet and Cancer Study. Int J Cancer. 2018 Jul 1;143(1):52-62. doi: 10.1002/ijc.31302. Epub 2018 Feb 21. — View Citation

Andersson G, Wennersten C, Borgquist S, Jirstrom K. Pancreatic cancer risk in relation to sex, lifestyle factors, and pre-diagnostic anthropometry in the Malmo Diet and Cancer Study. Biol Sex Differ. 2016 Dec 9;7:66. doi: 10.1186/s13293-016-0120-8. eCollection 2016. — View Citation

Elebro J, Ben Dror L, Heby M, Nodin B, Jirstrom K, Eberhard J. Prognostic effect of hENT1, dCK and HuR expression by morphological type in periampullary adenocarcinoma, including pancreatic cancer. Acta Oncol. 2016;55(3):286-96. doi: 10.3109/0284186X.2015.1075663. Epub 2015 Sep 11. — View Citation

Elebro J, Heby M, Gaber A, Nodin B, Jonsson L, Fristedt R, Uhlen M, Jirstrom K, Eberhard J. Prognostic and treatment predictive significance of SATB1 and SATB2 expression in pancreatic and periampullary adenocarcinoma. J Transl Med. 2014 Oct 17;12:289. doi: 10.1186/s12967-014-0289-8. — View Citation

Elebro J, Heby M, Warfvinge CF, Nodin B, Eberhard J, Jirstrom K. Expression and Prognostic Significance of Human Epidermal Growth Factor Receptors 1, 2 and 3 in Periampullary Adenocarcinoma. PLoS One. 2016 Apr 12;11(4):e0153533. doi: 10.1371/journal.pone.0153533. eCollection 2016. — View Citation

Fristedt R, Elebro J, Gaber A, Jonsson L, Heby M, Yudina Y, Nodin B, Uhlen M, Eberhard J, Jirstrom K. Reduced expression of the polymeric immunoglobulin receptor in pancreatic and periampullary adenocarcinoma signifies tumour progression and poor prognosis. PLoS One. 2014 Nov 14;9(11):e112728. doi: 10.1371/journal.pone.0112728. eCollection 2014. — View Citation

Heby M, Elebro J, Nodin B, Jirstrom K, Eberhard J. Prognostic and predictive significance of podocalyxin-like protein expression in pancreatic and periampullary adenocarcinoma. BMC Clin Pathol. 2015 May 30;15:10. doi: 10.1186/s12907-015-0009-1. eCollection 2015. — View Citation

Heby M, Lundgren S, Nodin B, Elebro J, Eberhard J, Jirstrom K. Relationship between mismatch repair immunophenotype and long-term survival in patients with resected periampullary adenocarcinoma. J Transl Med. 2018 Mar 14;16(1):66. doi: 10.1186/s12967-018-1444-4. — View Citation

Karnevi E, Dror LB, Mardinoglu A, Elebro J, Heby M, Olofsson SE, Nodin B, Eberhard J, Gallagher W, Uhlen M, Jirstrom K. Translational study reveals a two-faced role of RBM3 in pancreatic cancer and suggests its potential value as a biomarker for improved patient stratification. Oncotarget. 2017 Dec 15;9(5):6188-6200. doi: 10.18632/oncotarget.23486. eCollection 2018 Jan 19. — View Citation

Lundgren S, Karnevi E, Elebro J, Nodin B, Karlsson MCI, Eberhard J, Leandersson K, Jirstrom K. The clinical importance of tumour-infiltrating macrophages and dendritic cells in periampullary adenocarcinoma differs by morphological subtype. J Transl Med. 2017 Jul 3;15(1):152. doi: 10.1186/s12967-017-1256-y. — View Citation

Lundgren S, Warfvinge CF, Elebro J, Heby M, Nodin B, Krzyzanowska A, Bjartell A, Leandersson K, Eberhard J, Jirstrom K. The Prognostic Impact of NK/NKT Cell Density in Periampullary Adenocarcinoma Differs by Morphological Type and Adjuvant Treatment. PLoS One. 2016 Jun 8;11(6):e0156497. doi: 10.1371/journal.pone.0156497. eCollection 2016. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	months	5 years
Secondary	Time to progression	months	5 years
Secondary	Disease specific survival	months	5 years