Clinical trial NCT00254683: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Positron Emission Tomography
Fluorodeoxyglucose F18
Computed Tomography
Neoadjuvant Therapy
Chemotherapy
Radiotherapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2005-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: PET/CT specificity and sensitivity for tumor response
timeFrame: Response assesment at 6 and 8 weeks following neoadjuvant therapy
Secondary outcomes:
measure: Correlation between PET/CT and complete clinical Response
timeFrame: 2 years following completion of neoadjuvant therapy
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of São Paulo School of Medicine - Department of Gastroenterology
name: Angelita Habr-Gama, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of São Paulo School of Medicine - Department of Gastroenterology
name: Rodrigo O Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo School of Medicine - Department of Gastroenterology
name: Joaquim J Gama-Rodrigues, MD, PhD
role: STUDY_CHAIR
affiliation: University of São Paulo School of Medicine - Department of Radiology
name: Carlos A Buchpiguel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo School of Medicine - Department of Gastroenterology
name: Desedério R Kiss, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.