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Completed

NCT Number: NCT00682786

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

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.

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Key information

Conditions

Rectal Carcinoma Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5FU

Drug

Other names: Fluorouracil, 5-fluorouracil

Radiation

Radiation

Surgery of resectable lesions

Procedure

Irinotecan

Drug

Other names: Camptosar

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2002
Primary completion
2008
Study completion
2010
First posted
May 22, 2008
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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