Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
This study has been completed.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00682786
First received: April 11, 2008
Last updated: January 11, 2013
Last verified: January 2013
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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: 5FU Radiation: Radiation Procedure: Surgery of resectable lesions Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma |
Resource links provided by NLM:
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 ]
| Enrollment: | 135 |
| Study Start Date: | October 2002 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation, 5FU chemotherapy, Surgery
Radiation 45 Gy/25 fx to PTV1, 5FU 225 mg/m2/day by CIVI during radiation, surgery for resectable lesions
|
Drug: 5FU Radiation: Radiation Procedure: Surgery of resectable lesions |
|
Experimental: Radiation, 5FU chemo + irinotecan, Surgery
Radiation 45 Gy/25 fx to PTV1, 5FU 225 mg/m2/day by CIVI during radiation, irinotecan 50 mg/m2 once a week during radiation, surgery for resectable lesions
|
Drug: 5FU Radiation: Radiation Procedure: Surgery of resectable lesions Drug: Irinotecan |
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| Ages Eligible for Study: | 18 Years and older |
| 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).
- 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
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00682786 History of Changes |
| Other Study ID Numbers: | 02-0561 |
| Study First Received: | April 11, 2008 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
rectal rectum cancer carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Rectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Fluorouracil |
Irinotecan Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013