American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

CRP Investigator Webinar: Lower GI (NCCTG N1048 and NRG-G002)

A Surgical Investigators Meeting Webinar focusing on Ongoing Rectal Cancer Trials.

Sponsored by the ALLIANCE/American College of Surgeons Clinical Research Program

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Recorded November 17, 2017

Presentation Slides

Moderator: Y. Nancy You, MD MHSc, Education Committee, ACS CRP
Speakers: Martin Weiser, MD and Thom George, MD
Trials Covered: NCCTG N1048 and NRG-G002


A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

The ALLIANCE trial PROSPECT challenges the current treatment paradigm for rectal cancer. The PROSPECT trial attempts to individualize treatment by using radiotherapy selectively rather than reflexively.

The rationale for using radiation selectively in rectal cancer patients includes:

  • Better rectal cancer risk stratification—not all patients are at high risk for local recurrence
  • Minimize risk of short- and long-term toxicity
  • Enable more patients complete the prescribed multimodality regimen
  • Ability to move systemic therapy proximally to potentially reduce distant recurrence, which is the major threat to longevity

N1048/PROSPECT Trial Schema

PROSPECT Trial Schema


Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy in Rectal Cancer

Outcomes for locally advanced rectal cancer (LARC) have been limited by inconsistent delivery of adjuvant therapy and ineffective novel therapies. Systematic testing of new chemotherapy and radiation sensitizers are needed to advance treatment outcomes. This randomized phase II modular clinical trial platform utilizes Total Neoadjuvant Therapy (TNT) with parallel experimental arms. The experimental arms test a variety of sensitizers or hypotheses in a consistent high-risk patient population. Success of any given experimental arm will be determined by achievement of pathologic endpoints compared to the control arm.

Eligible patients/tumors are defined as meeting any one of the following criteria:

  • Distal location (as defined by measurement on MRI, ERUS/pelvic CT scan or palpable on digital rectal exam [DRE]): cT3-4 ≤ 5 cm from the anal verge, any N
  • Bulky: any cT4 with the majority of the untreated tumor < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon, or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT scan
  • High risk for metastatic disease with 4 or more regional lymph nodes (cN2)
  • Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)

NRG GI-002 (TNT) Schema

NRG GI 002 Schema

About the Speakers and Program

More about Martin R. Weiser, MD, FAC

Dr. Weiser is vice-chair, education and faculty development, department of surgery, and Stuart H.Q. Quan Chair in colorectal surgery, Memorial Sloan Kettering Cancer Center, New York, NY.

More about Thom George, MD, FACP

Dr. George is a clinical investigator and educator with a focus on gastrointestinal malignancies. As medical director of the GI Oncology Program at the University of Florida, Dr. George oversees the treatment of all patients with GI malignancies.

More about Y. Nancy You, MD MHSc, Education Committee, ACS CRP

Dr. You is associate professor, section of colorectal surgery, department of surgical oncology and medical director, Familial High Risk Gastrointestinal Cancer Clinic at the University of Texas MD Anderson Cancer Center. She is Vice-Chair, ACS CRP Education Committee

More about ALLIANCE/ACS Clinical Research Program

The mission of the ALLIANCE/American College of Surgeons Clinical Research Program (ACS CRP) is to reduce the impact of cancer by increasing knowledge and awareness of new evidence and practice standards; increasing the participation of community oncology surgeons in cancer research and cancer care activities; developing and implementing evidence-based practices in surgical oncology; and creating opportunities for meaningful health services research.