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Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00682786
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : September 8, 2014
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Carcinoma Drug: 5FU Radiation: Radiation Procedure: Surgery of resectable lesions Drug: Irinotecan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Study Start Date : October 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)

Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.

 Drug: 5FU
Other Names:
  • Fluorouracil
  • 5-fluorouracil

Radiation: Radiation
Procedure: Surgery of resectable lesions
Experimental: Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)

Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Irinotecan 50 mg/m2 IV weekly for 5 doses.

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.

 Drug: 5FU
Other Names:
  • Fluorouracil
  • 5-fluorouracil

Radiation: Radiation
Procedure: Surgery of resectable lesions
Drug: Irinotecan
Other Name: Camptosar


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Tumor Downstaging Compared With Historical Controls. [ Time Frame: 1 year after enrollment ]

    Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.

    Historical studies demonstrate a DS rate of 45%.



Secondary Outcome Measures :
  1. Complete Response Rates [ Time Frame: 1 year after enrollment ]

    Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).

    Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).

    pCR rate of historical controls is 8%-14%.


  2. Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. [ Time Frame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy ]
    The questionnaire is encouraged but not required.

  3. Determine Patient Fears and Expectations of Pharmacogenetics. [ Time Frame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy ]
    The questionnaire is encouraged but not required.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682786


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00682786    
Other Study ID Numbers: 02-0561
First Posted: May 22, 2008    Key Record Dates
Results First Posted: September 8, 2014
Last Update Posted: October 6, 2017
Last Verified: September 2017
Keywords provided by Washington University School of Medicine:
rectal
rectum
cancer
carcinoma
Additional relevant MeSH terms:
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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
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors