Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

NCT ID: NCT02318095

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-17
• Study Completion Date: 2022-11-14

Brief Summary

This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer

Detailed Description

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection.

Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.

Conditions

Resectable Pancreatic Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy/radiation/surgery

This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.

Group Type: OTHER

Gemcitabine/nab-Paclitaxel

Intervention Type: DRUG

Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.

Radiation therapy

Intervention Type: RADIATION

5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.

Sugical resection

Intervention Type: OTHER

Surgical resection of the pancreas post radiation therapy

Adjuvant chemotheapy

Intervention Type: DRUG

Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist

Interventions

Gemcitabine/nab-Paclitaxel

Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.

Intervention Type: DRUG

Radiation therapy

5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.

Intervention Type: RADIATION

Sugical resection

Surgical resection of the pancreas post radiation therapy

Intervention Type: OTHER

Adjuvant chemotheapy

Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient has signed informed consent and is willing to comply with the protocol

2. Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)

3. Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])

4. Patient is 18 years or older

5. Karnofsky performance status 70 or greater

6. The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL

7. Laboratory values meet the following constraints: Bilirubin less than or equal to 2 mg/dL; AST and ALT less than or equal to 3 x ULN (stenting to improve biliary obstruction is permitted)

8. No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis.

Exclusion Criteria

1. Metastatic disease on pretreatment imaging

2. Prior systemic therapy

3. Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI

4. Previous treatment for pancreatic cancer

5. Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance

6. Pregnant or lactating. Adequate birth control must be used if of child bearing potential per institutional policy. Negative pregnancy test in female patients of child-bearing potential per institutional policy. Post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing

7. Clinically significant peripheral vascular disease

8. Presence of active or chronic infection

9. Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart Class II/III/IV CHF, ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months

10. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start

11. History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis)

12. Current grade 2 or higher peripheral neuropathy

13. Anticoagulation with warfarin

14. History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months

15. Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Palta, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke Cancer Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00058865

Identifier Type: -

Identifier Source: org_study_id