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Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy

Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

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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:


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:


Principal Investigator

Angelita Habr-Gama, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of São Paulo School of Medicine - Department of Gastroenterology


Brazil: National Committee of Ethics in Research

Study ID:




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