Rectal Cancer
Conditions
Keywords
Rectal Cancer, Positron Emission Tomography, Fluorodeoxyglucose F18, Computed Tomography, Neoadjuvant Therapy, Chemotherapy, Radiotherapy
Brief summary
Preoperative chemoradiation therapy is the preferred initial treatment option for distal rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy remains a challenge to the colorectal surgeon, especially when determining if there is a complete response, observed in more than 10% of cases. The purpose of this study is to evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative chemoradiation therapy.
Detailed description
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.
Interventions
PET/CT before start of neoadjuvant CRT, at 6 weeks, 12 weeks, following CRT completion and 12mo, 24mo following CRT for those considered complete responders
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET/CT specificity and sensitivity for tumor response | Response assesment at 6 and 8 weeks following neoadjuvant therapy |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between PET/CT and complete clinical Response | 2 years following completion of neoadjuvant therapy |
Countries
Brazil