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

NCT ID: NCT00254683

Last Updated: 2009-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

PET/CT

Single arm study evaluating the use of PET/CT to assess rectal cancer response to neoadjuvant therapy

Group Type: EXPERIMENTAL

PET/CT with FDG

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

PET-CT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

University of São Paulo

Principal Investigators

Angelita Habr-Gama, MD, PhD

Role: STUDY_DIRECTOR

University of São Paulo School of Medicine - Department of Gastroenterology

Rodrigo O Perez, MD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo School of Medicine - Department of Gastroenterology

Joaquim J Gama-Rodrigues, MD, PhD

Role: STUDY_CHAIR

University of São Paulo School of Medicine - Department of Gastroenterology

Carlos A Buchpiguel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo School of Medicine - Department of Radiology

Desedério R Kiss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo School of Medicine - Department of Gastroenterology

Locations

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rodrigo O Perez, MD

Role: CONTACT

rodrigo.operez@gmail.com

55-11-3887-1757

Igor Proscurshim, MD

Role: CONTACT

praksurkin@gmail.com

55-11 9993-4253

Facility Contacts

Rodrigo O Perez, MD

Role: primary

rodrigo.operez@gmail.com

55-11-3887-1757

Igor Proscurshim, BS

Role: backup

praskurkin@gmail.com

55-11-9993-4253

References

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.

Reference Type: DERIVED

PMID: 26911200 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24509716 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22580120 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22086847 (View on PubMed)

Other Identifiers

717/05

Identifier Type: -

Identifier Source: org_study_id