Prognostic and Predictive Markers of Treatment Response in Patients With PAC.

Pancreatic Adenocarcinoma Clinical Trial

— CANOPE  

Official title:

Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776342
• Other study ID #: CANOPE GB-121
• Status: Recruiting
• Start date: January 1, 2003
• Est. completion date: December 31, 2031

Study information

• Verified date: September 2023
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Angelique VIENOT, MD
• Phone: 01402985 00
• Email: regulatory.Affairs[@]gercor.com.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

Description:

The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.

The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4050
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with histologically confirmed pancreatic adenocarcinoma.

• Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery

• Diagnosis between January 1, 2003, and December 31, 2030.

• First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.

• Age = 18 years.

• Written informed consent

Exclusion Criteria:

• Patient under guardianship, curatorship, or judicial protection.

• Pregnant or breastfeeding women.

• Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.

• Refusal to participate in the study

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon
France	Hôpital Beaujon	Clichy
France	CHU - Henri Mondor	Créteil
France	CHU Lille	Lille
France	Centre Léon Bérard	Lyon
France	HRU Nancy Site Brabois	Nancy
France	Hôpital Georges Pompidou	Paris
France	Hôpital Saint Antoine	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHU Poitiers	Poitiers
France	CHU Reims	Reims
France	CHU Pontchaillou	Rennes
France	Institut Curie	Saint-Cloud
France	IHU - Institut de chirurgie guidée par l'imagerie	Strasbourg
France	Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) rate	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of death regardless of the cause. Living or lost to follow-up patients will be censored at the date of the last news	Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)
Secondary	Progression-free survival (PFS) rate	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of first progression or date of death regardless of the cause. Living patients without progression or lost to follow-up will be censored at the date of the last news	Up to 7 years
Secondary	Number of patient with objective response rate	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Secondary	Number of patient with stability rate	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Secondary	Number of patient with tumor progression	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Secondary	Number of patient with grade 3/4 treatment-related toxicities	Toxicity rates according to CTCAE v5.0 classification. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Secondary	Number of patients who received maintenance treatment in the first-line	Study the profiles of patients receiving maintenance treatment in 1st-line chemotherapy	Up to 7 years
Secondary	Number of patients who received second and third-line treatments	Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy	Up to 7 years