Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Rectal Carcinoma Clinical Trial

Official title:

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682786
• Other study ID #: 02-0561
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2008
• Last updated: September 7, 2017
• Start date: October 2002
• Est. completion date: August 2010

Study information

• Verified date: September 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Rectal Carcinoma
• Rectal Neoplasms

Intervention

Drug:
• 5FU

Radiation:
• Radiation

Procedure:
• Surgery of resectable lesions

Drug:
• Irinotecan

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Tumor Downstaging Compared With Historical Controls.	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%.	1 year after enrollment
Secondary	Complete Response Rates	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%.	1 year after enrollment
Secondary	Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.	The questionnaire is encouraged but not required.	Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Secondary	Determine Patient Fears and Expectations of Pharmacogenetics.	The questionnaire is encouraged but not required.	Prior to start of study treatment and 3-6 weeks post completion of radiation therapy

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine