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

University of Sao Paulo

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Device: PET/CT with FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT00254683

717/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 1 patient group

PET/CT

Experimental group

Description:

Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy

Treatment:

Device: PET/CT with FDG