Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy
18 Years
N/A
Both
Rectal Cancer
Trial Information
Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy
Patients with distal rectal adenocarcinoma will be submitted to an initial whole body PET/CT
prior to the preoperative chemoradiation therapy with 5-fluorouracil and 5040 cGy. Six weeks
and 12 weeks after the preoperative treatment is finished the PET/CT will be repeated. At 1
and at 2 years after preoperative treatment is concluded another PET/CT will be performed.
The colorectal surgeon evaluating the response to chemoradiation therapy will be blinded to
the results of the PET/CT, as the radiologist will be blinded to the response assessment.
PET/CT results will not be used to determine treatment strategy, unless metastatic disease
or other disease is diagnosed. Patients with a complete clinical response at 8 weeks will be
rigorously followed while patients with an incomplete clinical response at 8 weeks will be
submitted to radical surgery. PET/CT results will be compared to current radiological
studies and final pathological reports.
Inclusion Criteria:
- Diagnosis of Rectal Adenocarcinoma
- Location of Tumor less than 7cm from Anal Verge
Exclusion Criteria:
- Pregnancy or Nursing
- Metastatic Disease (Stage IV disease)
- Previous treatment for any cancer
- Patients clinically unable to receive neoadjuvant chemoradiotherapy
- Hypersensitivity to 18FDG
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
PET/CT specificity and sensitivity for tumor response
Outcome Time Frame:
Response assesment at 6 and 8 weeks following neoadjuvant therapy
Safety Issue:
No
Principal Investigator
Angelita Habr-Gama, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
University of São Paulo School of Medicine - Department of Gastroenterology
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
717/05
NCT ID:
NCT00254683
Start Date:
September 2005
Completion Date:
September 2015
Related Keywords:
- Rectal Cancer
- Rectal Cancer
- Positron Emission Tomography
- Fluorodeoxyglucose F18
- Computed Tomography
- Neoadjuvant Therapy
- Chemotherapy
- Radiotherapy
- Rectal Neoplasms
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