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Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Carcinoma

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

throughout trial participation

Safety Issue:

No

Principal Investigator

Benjamin Tan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

02-0561

NCT ID:

NCT00682786

Start Date:

October 2002

Completion Date:

August 2010

Related Keywords:

  • Rectal Carcinoma
  • rectal
  • rectum
  • cancer
  • carcinoma
  • Carcinoma
  • Rectal Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110