Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
PET/CT with FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Cancer focused on measuring Rectal Cancer, Positron Emission Tomography, Fluorodeoxyglucose F18, Computed Tomography, Neoadjuvant Therapy, Chemotherapy, Radiotherapy
Eligibility 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
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT
Arm Description
Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy
Outcomes
Primary Outcome Measures
PET/CT specificity and sensitivity for tumor response
Secondary Outcome Measures
Correlation between PET/CT and complete clinical Response
Full Information
NCT ID
NCT00254683
First Posted
November 15, 2005
Last Updated
April 13, 2009
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00254683
Brief Title
Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer
Official Title
Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, Positron Emission Tomography, Fluorodeoxyglucose F18, Computed Tomography, Neoadjuvant Therapy, Chemotherapy, Radiotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET/CT
Arm Type
Experimental
Arm Description
Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy
Intervention Type
Device
Intervention Name(s)
PET/CT with FDG
Other Intervention Name(s)
PET-CT
Intervention Description
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
Primary Outcome Measure Information:
Title
PET/CT specificity and sensitivity for tumor response
Time Frame
Response assesment at 6 and 8 weeks following neoadjuvant therapy
Secondary Outcome Measure Information:
Title
Correlation between PET/CT and complete clinical Response
Time Frame
2 years following completion of neoadjuvant therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo O Perez, MD
Phone
55-11-3887-1757
Email
rodrigo.operez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Proscurshim, MD
Phone
55-11 9993-4253
Email
praksurkin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelita Habr-Gama, MD, PhD
Organizational Affiliation
University of São Paulo School of Medicine - Department of Gastroenterology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rodrigo O Perez, MD
Organizational Affiliation
University of São Paulo School of Medicine - Department of Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquim J Gama-Rodrigues, MD, PhD
Organizational Affiliation
University of São Paulo School of Medicine - Department of Gastroenterology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos A Buchpiguel, MD, PhD
Organizational Affiliation
University of São Paulo School of Medicine - Department of Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desedério R Kiss, MD, PhD
Organizational Affiliation
University of São Paulo School of Medicine - Department of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo O Perez, MD
Phone
55-11-3887-1757
Email
rodrigo.operez@gmail.com
First Name & Middle Initial & Last Name & Degree
Igor Proscurshim, BS
Phone
55-11-9993-4253
Email
praskurkin@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26911200
Citation
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.
Results Reference
derived
PubMed Identifier
24509716
Citation
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.
Results Reference
derived
PubMed Identifier
22580120
Citation
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.
Results Reference
derived
PubMed Identifier
22086847
Citation
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.
Results Reference
derived
Learn more about this trial
Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer
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