Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer
April 13, 2009 updated by: University of Sao Paulo
Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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São Paulo, SP, Brazil, 05403-010
- Recruiting
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
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Contact:
- Rodrigo O Perez, MD
- Phone Number: 55-11-3887-1757
- Email: rodrigo.operez@gmail.com
-
Contact:
- Igor Proscurshim, BS
- Phone Number: 55-11-9993-4253
- Email: praskurkin@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PET/CT
Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PET/CT specificity and sensitivity for tumor response
Time Frame: Response assesment at 6 and 8 weeks following neoadjuvant therapy
|
Response assesment at 6 and 8 weeks following neoadjuvant therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between PET/CT and complete clinical Response
Time Frame: 2 years following completion of neoadjuvant therapy
|
2 years following completion of neoadjuvant therapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Habr-Gama A, Perez RO, Sao Juliao GP, Proscurshim I, Fernandez LM, Figueiredo MN, Gama-Rodrigues J, Buchpiguel CA. Consolidation chemotherapy during neoadjuvant chemoradiation (CRT) for distal rectal cancer leads to sustained decrease in tumor metabolism when compared to standard CRT regimen. Radiat Oncol. 2016 Feb 24;11:24. doi: 10.1186/s13014-016-0598-6.
- Perez RO, Habr-Gama A, Sao Juliao GP, Lynn PB, Sabbagh C, Proscurshim I, Campos FG, Gama-Rodrigues J, Nahas SC, Buchpiguel CA. Predicting complete response to neoadjuvant CRT for distal rectal cancer using sequential PET/CT imaging. Tech Coloproctol. 2014 Aug;18(8):699-708. doi: 10.1007/s10151-013-1113-9. Epub 2014 Feb 8.
- Perez RO, Habr-Gama A, Sao Juliao GP, Gama-Rodrigues J, Sousa AH Jr, Campos FG, Imperiale AR, Lynn PB, Proscurshim I, Nahas SC, Ono CR, Buchpiguel CA. Optimal timing for assessment of tumor response to neoadjuvant chemoradiation in patients with rectal cancer: do all patients benefit from waiting longer than 6 weeks? Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1159-65. doi: 10.1016/j.ijrobp.2012.01.096. Epub 2012 May 12.
- Perez RO, Habr-Gama A, Gama-Rodrigues J, Proscurshim I, Juliao GP, Lynn P, Ono CR, Campos FG, Silva e Sousa AH Jr, Imperiale AR, Nahas SC, Buchpiguel CA. Accuracy of positron emission tomography/computed tomography and clinical assessment in the detection of complete rectal tumor regression after neoadjuvant chemoradiation: long-term results of a prospective trial (National Clinical Trial 00254683). Cancer. 2012 Jul 15;118(14):3501-11. doi: 10.1002/cncr.26644. Epub 2011 Nov 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Anticipated)
August 1, 2010
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
November 15, 2005
First Submitted That Met QC Criteria
November 15, 2005
First Posted (Estimate)
November 16, 2005
Study Record Updates
Last Update Posted (Estimate)
April 14, 2009
Last Update Submitted That Met QC Criteria
April 13, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 717/05
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