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

Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00254683
Enrollment
100
Registered
2005-11-16
Start date
2005-09-30
Completion date
2015-09-30
Last updated
2009-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal Cancer, Positron Emission Tomography, Fluorodeoxyglucose F18, Computed Tomography, Neoadjuvant Therapy, Chemotherapy, Radiotherapy

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.

Interventions

DEVICEPET/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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
PET/CT specificity and sensitivity for tumor responseResponse assesment at 6 and 8 weeks following neoadjuvant therapy

Secondary

MeasureTime frame
Correlation between PET/CT and complete clinical Response2 years following completion of neoadjuvant therapy

Countries

Brazil

Contacts

Primary ContactRodrigo O Perez, MD
rodrigo.operez@gmail.com55-11-3887-1757
Backup ContactIgor Proscurshim, MD
praksurkin@gmail.com55-11 9993-4253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026