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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT | Experimental | Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT with FDG | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PET/CT specificity and sensitivity for tumor response | Response assesment at 6 and 8 weeks following neoadjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between PET/CT and complete clinical Response | 2 years following completion of neoadjuvant therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo O Perez, MD | Contact | 55-11-3887-1757 | rodrigo.operez@gmail.com | |
| Igor Proscurshim, MD | Contact | 55-11 9993-4253 | praksurkin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Angelita Habr-Gama, MD, PhD | University of São Paulo School of Medicine - Department of Gastroenterology | Study Director |
| Rodrigo O Perez, MD | University of São Paulo School of Medicine - Department of Gastroenterology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26911200 | Derived | 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. | |
| 24509716 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 25, 2014 | |
| Reset | Jun 28, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2014 | Jun 28, 2014 |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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|
| Joaquim J Gama-Rodrigues, MD, PhD | University of São Paulo School of Medicine - Department of Gastroenterology | Study Chair |
| 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 | Principal Investigator |
| 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. |
| 22580120 | Derived | 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. |
| 22086847 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |