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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2009 by University of Sao Paulo
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00254683
First received: November 15, 2005
Last updated: April 13, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Device: PET/CT with FDG
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • PET/CT specificity and sensitivity for tumor response [ Time Frame: Response assesment at 6 and 8 weeks following neoadjuvant therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between PET/CT and complete clinical Response [ Time Frame: 2 years following completion of neoadjuvant therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET/CT
Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy
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
Other Name: PET-CT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254683

Contacts
Contact: Rodrigo O Perez, MD 55-11-3887-1757 rodrigo.operez@gmail.com
Contact: Igor Proscurshim, MD 55-11 9993-4253 praksurkin@gmail.com

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, SP, Brazil, 05403-010
Contact: Rodrigo O Perez, MD    55-11-3887-1757    rodrigo.operez@gmail.com   
Contact: Igor Proscurshim, BS    55-11-9993-4253    praskurkin@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Angelita Habr-Gama, MD, PhD University of São Paulo School of Medicine - Department of Gastroenterology
Principal Investigator: Rodrigo O Perez, MD University of São Paulo School of Medicine - Department of Gastroenterology
Study Chair: Joaquim J Gama-Rodrigues, MD, PhD University of São Paulo School of Medicine - Department of Gastroenterology
Principal Investigator: Carlos A Buchpiguel, MD, PhD University of São Paulo School of Medicine - Department of Radiology
Principal Investigator: Desedério R Kiss, MD, PhD University of São Paulo School of Medicine - Department of Gastroenterology
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo Oliva Perez, University of São Paulo
ClinicalTrials.gov Identifier: NCT00254683     History of Changes
Other Study ID Numbers: 717/05
Study First Received: November 15, 2005
Last Updated: April 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Rectal Cancer
Positron Emission Tomography
Fluorodeoxyglucose F18
Computed Tomography
Neoadjuvant Therapy
Chemotherapy
Radiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014