Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003591
First received: November 1, 1999
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic, unresectable pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: paclitaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • To determine the one-year and median survival rates after PXRT [ Designated as safety issue: No ]
    To determine the one-year and median survival rates after paclitaxel and external beam radiation therapy (PXRT)


Secondary Outcome Measures:
  • To determine the response rate of PXRT in unresectable pancreatic cancer in a multi-center trial [ Designated as safety issue: No ]
  • To evaluate the acute and late treatment morbidity of paclitaxel in a multi-institutional setting [ Designated as safety issue: No ]
  • To correlate p53 status with treatment response to PXRT [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: November 1998
Study Completion Date: October 2005
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pacilitaxel + External Beam Radiation Therapy (PXRT)
Paclitaxel 50 mg/m2 given on Days 1, 8, 15, 22, 29 and 36. Radiation therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day in 5.5 weeks.
Drug: paclitaxel Radiation: radiation therapy

Detailed Description:

OBJECTIVES: I. Determine the response rate of patients with nonmetastatic, unresectable pancreatic cancer receiving external beam irradiation and weekly paclitaxel. II. Determine the median survival after this treatment in these patients. III. Evaluate the acute and late treatment morbidity of paclitaxel in these patients. IV. Correlate p53 status with treatment response to this treatment in this patient population.

OUTLINE: This is a open label, multicenter study. Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases. Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 1.5 hours later by external beam radiotherapy daily 5 days a week for 5.5 weeks beginning on day 1. All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy. If there is marked response to treatment at this time, curative surgery may be attempted at the discretion of the attending surgeon. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for years 3-5, and annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued into this study over 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed nonmetastatic, unresectable pancreatic adenocarcinoma No evidence of metastatic disease in the major viscera and no peritoneal seeding Residual disease after resection (R-1 or -2 micro- and macroscopic residual) eligible if measurable disease on the post operative CT or MRI scan Recurrent disease following radical surgery is eligible All malignant disease must be encompassable within a single irradiation field Must be a radiographically assessable disease CT with 5 mm cuts or spiral CT

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Biliary system stented Renal: Creatinine less than 3.0 mg/dL OR Creatinine clearance at least 40 mL/min Other: If patients have biliary or gastroduodenal obstruction, they must have drainage prior to starting chemoradiation Oral intake of at least 1,500 calories per day No significant infection or other coexistent medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel At least 4 weeks since prior gemcitabine No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the planned field Surgery: See Disease Characteristics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003591

  Show 234 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Tyvin A. Rich, MD University of Virginia
  More Information

Additional Information:
Publications:
Konski AA, Winter K, Khor L, et al.: Over-expression of RIa subunit (RIas) of protein kinase A may be a marker for favorable pancreatic cancer: an analysis of patients treated on Radiation Therapy Oncology Group (RTOG) 98-12. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-148, 2006.
Rich T, Harris J, Abrams R, et al.: A phase II study of external irradiation and weekly paclitaxel for non-metastatic, unresectable pancreatic cancer: a preliminary report of RTOG protocol 98-12. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-51, 29-30, 2001.
Garofalo MC, Winter K, Regine WF, et al.: Recursive partitioning analysis (RPA) of prognostic factors in six Radiation Therapy Oncology Group (RTOG) trials of chemoradiotherapy for unresectable pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-144, S80-1, 2006.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003591     History of Changes
Other Study ID Numbers: RTOG-9812, CDR0000066661
Study First Received: November 1, 1999
Last Updated: November 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014