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Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
This study has been completed.
Study NCT00010166   Information provided by Wake Forest University Baptist Medical Center
First Received: February 2, 2001   Last Updated: August 20, 2009   History of Changes

February 2, 2001
August 20, 2009
December 2000
 
 
 
Complete list of historical versions of study NCT00010166 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

OBJECTIVES:

  • Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.

Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.

Phase II
Interventional
Treatment
Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
 
Blackstock AW, Mornex F, Partensky C, Descos L, Case LD, Melin SA, Levine EA, Mishra G, Limentani SA, Kachnic LA, Tepper JE. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. Br J Cancer. 2006 Aug 7;95(3):260-5. Epub 2006 Jul 25.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the pancreas

    • Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months
  • No clinical evidence of gross residual disease at time of surgery

    • No focally positive margins (tumor at the margin)
  • No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months

Hematopoietic:

  • Granulocyte count greater than 1,500/mm3
  • Hemoglobin greater than 10 g/dL
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • Able to maintain adequate oral nutrition
  • Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study
  • No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
  • Non-metastatic prostate cancer allowed if more than 2 year survival likely
  • No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent routine growth factors

Chemotherapy:

  • No prior chemotherapy for pancreatic cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior abdominal radiotherapy for pancreatic cancer

Surgery:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010166
 
CDR0000068452, CCCWFU-57198, NCI-104
Wake Forest University Baptist Medical Center
National Cancer Institute (NCI)
Study Chair: Arthur William Blackstock, MD Wake Forest University
Wake Forest University Baptist Medical Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP