A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

NCT01240304 | Terminated Phase 2 Results

• 1 other identifier: 112748
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head, assess margin-negative resection rates, disease-free survival, assess overall survival rates, and determine patterns of local and distant recurrence.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Margin-negative Resection Rate

  This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.

  An average of 6 years

Study Arms (1)

Gemcitabine, radiation therapy, surgery

EXPERIMENTAL

Drug: Gemcitabine; Radiation: Radiation therapy; Procedure: pancreaticoduodenectomy

Interventions

Gemcitabine DRUG

The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.

Also known as: Gemzar

Gemcitabine, radiation therapy, surgery

Radiation therapy RADIATION

The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.

Gemcitabine, radiation therapy, surgery

pancreaticoduodenectomy PROCEDURE

Surgery will be planned 28 days (+/- 3 days) after the last dose of chemotherapy. The liver and pancreas will be examined by palpation and inspection. In the absence of metastases, tumor mobilization and surgical resection will be performed with standard surgical technique.

Also known as: Removal of pancreas

Gemcitabine, radiation therapy, surgery

Eligibility Criteria

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

You may qualify if:

• Ages 18 years and above. There will be no upper age restriction.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale).
• Cytologic or histologic proof of adenocarcinoma of pancreas.
• Adequate renal, and bone marrow function:
• Leukocytes \>= 3,000/uL (upper limit)
• Absolute neutrophil count \>= 1,500/uL (upper limit)
• Platelets \>= 100,000/Ul
• Serum creatinine \<= 2.0 mg/dL
• Hepatic function (endoscopic or percutaneous drainage as needed)
• a. Aspartate aminotransferase (AST)-(SGOT)/Alanine aminotransferase (ALT) (SGPT) \<= 5 X institutional ULN (upper limit of normal)
• Borderline resectable pancreatic cancer:
• Short segment hepatic artery abutment (\< 180° involvement)
• Tumor abutment (\<180° ) of superior mesenteric artery
• Superior mesenteric/portal vein involvement beyond that of a simple resection and reconstruction
• Pancreatitis that obscures the determination of vessel involvement and may preclude an otherwise curative operation

You may not qualify if:

• Infections such as cholangitis, pneumonia, or wound infections that would preclude protocol therapy.
• Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
• Subjects cannot have known heptic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy/laparoscopy prior to treatment.
• Subjects with unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure will be excluded (see Appendix B).
• Known presence of central nervous system or brain metastases
• Subjects with prior radiotherapy to the upper abdomen or liver will be excluded.
• Subjects will be excluded if deemed unable to comply with study and/or follow-up procedures.
• Subjects with a known hypersensitivity to Gemzar are excluded.
• Multiple positive lymph nodes, which will make the radiotherapy treatment volume too large. Peripancreatic involved nodes can be included in the radiotherapy treatment volume if the field of involved nodes is less than 7.5cm.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy; Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Beth Scanlan
• Organization: University of Arkansas for Medical Sciences

bscanlan@uams.edu

501-686-8274

Study Officials

• Issam Makhoul, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-11

Locations

US (1)