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

NCT01751516 | Completed DMC

• 1 other identifier: LCCC1225
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology

  4-8 weeks post-chemoradiation

Secondary Outcomes (3)

• Recurrence-free survival

  5 years

• Disease-specific survival

  5 years

• Overall survival

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC Hospitals

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Joel E Tepper, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 18, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: March 4, 2018
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

US (1)