Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Device: PET/CT with FDG

• Registration Number: NCT00254683
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-16
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-13
• Last Update Posted: 2009-04-14
• Primary Completion: 2010-08
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of Rectal Adenocarcinoma
• Location of Tumor less than 7cm from Anal Verge

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT	PET/CT with FDG	Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy

Primary Outcome Measures

Name	Time	Method
PET/CT specificity and sensitivity for tumor response	Response assesment at 6 and 8 weeks following neoadjuvant therapy

Secondary Outcome Measures

Name	Time	Method
Correlation between PET/CT and complete clinical Response	2 years following completion of neoadjuvant therapy

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil