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

NCT00254683 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-04-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PET/CT with FDG

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 & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Angelita Habr-Gama, MD, PhD · University of São Paulo School of Medicine - Department of Gastroenterology

  • Rodrigo O Perez, MD · University of São Paulo School of Medicine - Department of Gastroenterology

  • Joaquim J Gama-Rodrigues, MD, PhD · University of São Paulo School of Medicine - Department of Gastroenterology

  • Carlos A Buchpiguel, MD, PhD · University of São Paulo School of Medicine - Department of Radiology

  • Desedério R Kiss, MD, PhD · University of São Paulo School of Medicine - Department of Gastroenterology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2010-08-31
Completion
2015-09-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254683 on ClinicalTrials.gov