PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01751516
First received: December 13, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.


Condition
Rectal Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology [ Time Frame: 4-8 weeks post-chemoradiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

UNC Hospitals

Criteria

Inclusion Criteria:

  • Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
  • Negative workup for distant disease
  • > 18 years of age
  • Pre-treatment workup completed including:
  • history and physical
  • CT or MRI of the abdomen and pelvis
  • endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
  • if female of child-bearing age, negative pregnancy test
  • Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
  • Informed consent reviewed and signed

Exclusion Criteria:

  • Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
  • Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
  • ANC ≤ 1,500/cubic mm³
  • Platelet count ≤ 100,000/mm³
  • ALT and AST ≥ 2.5 times upper level of normal (ULN)
  • Alkaline phosphatase ≥ 2.5 times ULN
  • Total bilirubin ≥ 1.5 times ULN
  • Creatinine clearance < 50 mL/min
  • Creatinine ≥ 1.5 times ULN
  • Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
  • Not deemed a surgical candidate
  • Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
  • Previous pelvic radiation therapy
  • History of severe reaction to gadolinium
  • Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
  • Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
  • Body Mass Index (BMI) > 35
  • Pregnant or lactating female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751516

Contacts
Contact: Dorothy A Riguera, BS 919-843-5420 riguera@email.unc.edu

Locations
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dorothy Riguera, BS    919-843-5420    riguera@email.unc.edu   
Principal Investigator: Joel Tepper, MD         
Sub-Investigator: Z. Andrew Wang, MD         
Sub-Investigator: Seth Miller, MD         
Sub-Investigator: Benjamin Calvo, MD         
Sub-Investigator: Amir Khandani, MD         
Sub-Investigator: Bert O'Neil, MD         
Sub-Investigator: Kevin Greene, MD         
Sub-Investigator: W. Brian Hyslop, MD, PhD         
Sub-Investigator: David Lalush, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Joel E Tepper, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01751516     History of Changes
Other Study ID Numbers: LCCC1225
Study First Received: December 13, 2012
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

ClinicalTrials.gov processed this record on October 21, 2014