Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma.

NCT03620461 | Completed DMC

• 1 other identifier: gitud
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus Gemcitabine between December 2013 and June 2015 according to the routine practice. Overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.

Conditions

Metastatic Pancreatic Cancer

Keywords

metastatic pancreatic cancer; real world data; gemcitabine; nabpaclitaxel; efficacy; safety

Outcome Measures

Primary Outcomes (3)

• overall survival

  Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel

  2 years

• progression free survival

  Evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel

  2 years

• Assess adverse events (per CTCAE v4.0 criteria)

  Assess the adverse events (per CTCAE v4.0 criteria) associated with the use of gemcitabine and nab-paclitaxel in real world setting.

  2 years

Interventions

Gemcitabine - nabpaclitaxel DRUG

efficacy and safety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,\[15\] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine

You may qualify if:

• Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites.
• Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
• No prior chemotherapy for metastatic pancreatic cancer.
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
• Age greater than or equal to 18 years.
• Patient has signed a Patient Informed Consent Form.
• Patients should have received at least one cycle of gemcitabine and nabpaclitaxel

You may not qualify if:

• less than one cycle of gemcitabine/nabpaclitaxel administrated.

Sponsors & Collaborators

• Galician Research Group on Digestive Tumors: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: August 8, 2018
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 30, 2015
• Last Updated: August 8, 2018

Record last verified: 2018-08