Genotype-Directed Neoadjuvant Chemoradiation for Rectal Carcinoma - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00682786

Purpose

Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.

Condition	Intervention	Phase
Rectal Carcinoma	Drug: Chemotherapy: 5FU and Chemotherapy: Irinotecan Radiation: Radiation: 45 Gy/25 Procedure: Surgery of resectable lesions	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Genotype-Directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Demonstrate objective response rates in high risk patients which are equal to or better than historic controls. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]
Define patient quality of life prior to and following neoadjuvant chemoradiation. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]
Determine patient fears and expectations of pharmacogenetics. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]
Discover additional genetic variants which predict for downstaging of rectal cancer after chemoradiation. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]

Estimated Enrollment:	135
Study Start Date:	October 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

5FU 225 mg/m2/day by continuous infusion during radiation OR 5FU 225mg/m2/day by continuous infusion and irinotecan 50mg/m2 once a week during radiation

45 Gy/25 fx to PTV1

Surgery for resectable lesions

Detailed Description:

Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy proven adenocarcinoma of the rectum
Lesion evaluated by surgeon and found to be resectable
Stage T3 or T4 disease on radiography or ultrasound
Karnofsky Performance Status at >60
Laboratory criteria:
- Absolute neutrophil count > 1.5 K
- Platelets > 100 K
- Total Bilirubin < 2.0;
- SGOT and Alkaline Phosphatase < 2 x upper limit of normal
- Creatinine < 2.0
Informed consent signed
Patients with distant metastatic disease will be eligible if they satisfy all other conditions.

Exclusion Criteria:

Pregnant women, children < 18 years, or patients unable to give informed consent
Patients with a past history of pelvic radiotherapy.
Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).

4 Patients with known allergy to 5-fluorouracil or irinotecan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682786

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Benjamin Tan, M.D.

Washington University School of Medicine

More Information

Responsible Party:	Washington University School of Medicine ( Benjamin Tan )
Study ID Numbers:	02-0561
Study First Received:	April 11, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00682786
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

rectal
rectum
cancer
carcinoma

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Irinotecan
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma

Rectal neoplasm
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009