The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with stage II or III colorectal cancer. These studies highlight dietary intervention, supplements, immunotherapy, combination chemotherapy, neoadjuvant therapy, and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

PILOT

Study Title: Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

Study Type: Pilot/interventional/single-group assignment

Study Sponsor and Collaborators: City of Hope Medical Center, National Cancer Institute, Hope Foundation

Purpose: To study how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I–III rectosigmoid cancer survivors

Primary Outcome Measures: Acceptability assessed by semistructured interview; bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool; feasibility assessed by patient enrollment; quality of life assessed by City of Hope–Quality of Life–Colorectal Cancer [time frame: up to 6 months]

Principal Investigator: Virginia Sun, PhD, RN, City of Hope Medical Center; (626) 256-4673 ext 63122, vsun@coh.org

ClinicalTrials.gov Identifier: NCT03063918

Study Title: Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer

Study Type: Pilot/interventional/parallel assignment

Study Sponsor and Collaborators: Legacy Health System

Purpose: To test whether there is an association between baseline vitamin D levels, vitamin D supplementation, and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy

Primary Outcome Measures: Increase in serum vitamin D3 level during chemotherapy in the active supplementation group compared with the control group [time frame: 1 year]

Principal Investigator: Eric C. Anderson, MD, Oregon Health and Science University; contact Jennifer Stubbs, BS, (503) 413-7202, jstubbs@lhs.org

ClinicalTrials.gov Identifier: NCT02603757

PHASE II

Study Title: Phase II Trial of Neoadjuvant Bevacizumab With Modified FOLFOX7 in Patients With Stage II and III Rectal Cancer

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: University of Southern California, National Cancer Institute

Purpose: To study the efficacy of bevacizumab (Avastin), fluorouracil, leucovorin calcium, and oxaliplatin before surgery in treating patients with stage II–III rectal cancer

Primary Outcome Measures: Rate of complete pathologic response [time frame: up to 3 years]

Principal Investigator: Afsaneh Barzi, MD, University of Southern California; contact Zeno Asahi, (323) 865-0463, zeno.ashai@med.usc.edu

ClinicalTrials.gov Identifier: NCT01871571

Study Title: A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy in Rectal Cancer

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study veliparib with combination chemotherapy and radiation therapy in treating patients with locally advanced rectal cancer

Primary Outcome Measures: Change in neoadjuvant rectal cancer score [time frame: baseline to up to 3 years]

Principal Investigator: Thomas George, MD, FACP, NRG Oncology; see clinicaltrials.gov for study locations and contact information

ClinicalTrials.gov Identifier: NCT02921256

Study Title: A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Antiangiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, KRAS Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Study Type: Phase II/interventional

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the effectiveness of cetuximab (Erbitux) and irinotecan hydrochloride with or without ramucirumab (Cyramza) in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy

Primary Outcome Measures: Progression-free survival

Principal Investigator: Howard S. Hochster, MD, New York University School of Medicine; see clinicaltrials.gov for list of study locations and contact information

ClinicalTrials.gov Identifier:  NCT01079780

PHASE III

Study Title: Randomized Placebo-Controlled Study Evaluating Regorafenib Followed by Standard Chemotherapy for Patients With Stage III Colon Cancer (ARGO)

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Academic and Community Cancer Research United (ACCRU)

Purpose: To determine the value of regorafenib (Stivarga) in improving disease-free survival in patients with resected colon cancer who have a high risk of recurrence after standard adjuvant chemotherapy

Primary Outcome Measures: Disease-free survival in patients with stage IIIB or IIIC colon cancer. Additional endpoints include overall survival, compliance and toxicity.

Principal Investigator: Tatjana Kolvesky, MD, Tatjana.Kolevska@kp.org; NSABP Foundation contact, Samuel Jacobs, MD, (412) 339-5300; visit clinicaltrials.gov to see all recruiting locations and individual contact information

ClinicalTrials.gov Identifier: NCT02664077 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.