E-Newsletter - February 2022
Spotlight on Alliance Trials
MARCH IS ... National colorectal cancer Awareness month
Colorectal cancer (CRC) is the second most common cause of cancer-related deaths in the United States. CRC strikes men and women with almost equal frequency, while someone with a family history of colorectal cancer has a 10 to 15 percent chance of developing the disease. Currently, Alliance has three active CRC trials now enrolling participants. Take a look.
Frank Sinicrope, MD, of the Mayo Clinic in Rochester, MN leads Alliance A021502 (Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC)).
Alliance A021502 is an active phase III trial that studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer. this trial opened on September 12, 2017. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT02912559) | Alliance Member Site
Kimmie Ng, MD, of Dana-Farber Cancer Institute, leads Alliance A021703 (Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)).
Alliance A021703 (SOLARIS) is a phase III trial that looks at how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab). This trial opened on September 30, 2019. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT04094688) | Alliance Member Site
Ellen M. Lavoie Smith, PhD, RN, FAAN, of the University of Alabama School of Nursing, leads Alliance A221805 (Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study).
Alliance A221805 is a phase II/III trial that studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy. The trial opened on May 1, 2020. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT04137107) | Alliance Member Site
For other articles in this issue of the Alliance E-News newsletter, see below.
- Message From the Group Statistician - Sumithra J. Mandrekar, PhD
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Navigating Ethical Dilemmas, Guiding Investigators During the Conduct of Oncology Clinical Trials
Fay J. Hlubocky, PhD, MA, and Jeffrey M. Peppercorn, MD, MPH - Co-Chairs, Alliance Ethics Committee -
Increased Skill Level, Training of Clinical Research Professionals Now Required to Meet Complexities of New Clinical Trials
Jennifer Dill, CCRP - Chair, Alliance Clinical Research Professionals Committee
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Spotlight on Alliance Trials
A211801 (BRCA-P Breast Cancer Prevention Study)
March is . . . -
National Colorectal Cancer Awareness Month
A021502: ATOMIC (DNA Mismatch Repair)
A021703: SOLARIS (Vitamin D Supplementation)
A221805 (Peripheral Neuropathy) -
National Kidney Cancer Awareness Month
A301704: PDIGREE (Metastatic Untreated RCC)
A031801: RadiCaL (Advanced RCC/Bone Metastasis)
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Alliance Foundation Funding Opportunity
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Alliance in the News
Alliance A011502 | Aspirin Doesn’t Improve iDFS in Breast Cancer
Alliance A021804 | NCI Clinical Trial Spotlight: Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
AFT-05 (PALLAS) | Safety of Adjuvant CDK4/6 Inhibitors During the COVID-19 Pandemic
CALGB 90601 | Results of Bevacizumab-Chemotherapy Combinations for Patients with Advanced Urothelial Cancer - Expert Commentary
Alliance A041202 | Anti-CD20 Monoclonal Antibodies for Chronic Lymphocytic Leukemia
New Cancer Research | NCI Seeks to Develop Clinical Trial of MCED Tests
Cancer Research Opinion | Congressional Inaction Harms Federally Funded Oncology Research and Our Patients: The Time for the Cancer Community to Act is Now
Alliance Group Chair | Monica Bertagnolli, M.D., FACS joins Prevent Cancer Board of Directors
Alliance Ethics Committee Co-Chair | Jeffrey Peppercorn, MD, MPH, Named Editor-in-Chief of JCO Oncology Practice
Alliance Committee Co-Chair | Ian E. Krop, MD, PhD, Named Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research at Yale Cancer Center