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Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)
 
Region Sponsors
Northwest
NRG Oncology
 
Acronym KP IRB No.
1571026
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Male and Female with Histologically/pathologically confirmed Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8
 
Purpose
This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.
 
Detailed Description
PRIMARY OBJECTIVES: I. To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. (Phase II) II. To compare recurrence-free survival (RFS) in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. (Phase III). SECONDARY OBJECTIVES: I. To describe the prevalence of detectable ctDNA in patients with stage IIA colon cancer following surgical resection. II. To estimate time-to-event outcomes (overall survival [OS], recurrence-free survival [RFS], and time to recurrence [TTR]) by ctDNA marker status and treatment for patients with resected stage IIA colon cancer. III. To estimate the rate of compliance with adjuvant chemotherapy and/or active surveillance for patients with resected stage IIA colon cancer. EXPLORATORY OBJECTIVES: I. To describe the association of quantitative ctDNA levels with time to event outcomes (RFS, OS, and TTR). II. To characterize genomic profiles associated with recurrence using a ctDNA assay in patients with resected stage IIA colon cancer. III. To model the cost effectiveness of the use of ctDNA versus standard of care in this setting. IV. To evaluate performance of a ctDNA assay after incorporation of patient tumor and peripheral blood mononuclear cells. OUTLINE: Patients are randomized to 1 of 2 arms.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection
  • Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns
  • The distal extent of the tumor must be =/>12 cm from the anal verge on pre-surgical endoscopy (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be =/> 12 cm from the anal verge as determined by surgical examination or pre-operative imaging
  • The patient must have had an en bloc complete gross resection of tumor (curative resection) as definitive surgical cancer treatment within 14 to 60 days of study randomization. Patients who have had a two-stage surgical procedure to first provide a decompressive colostomy and then, in a later procedure, to have the definitive surgical resection, are eligible
  • Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.)
  • Pathologic, clinical, or radiologic evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected (including the presence of satellite nodules constituting N1c disease in the absence of lymph node involvement)
  • Tumor-related bowel perforation
  • History of prior invasive colon malignancy, regardless of disease-free interval
  • History of organ transplantation
  • Any prior systemic chemotherapy, targeted therapy, or immunotherapy, or radiation therapy administered as treatment for colorectal cancer (e.g., primary rectal adenocarcinomas for which treatment with neoadjuvant chemoradiation is warranted are not permitted)
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma
  • Folic Acid
  • Antimetabolites
  • Gastrointestinal Diseases
  • Antimetabolites, Antineoplastic
  • Gastrointestinal Neoplasms
  • Antineoplastic Agents
  • Intestinal Diseases
  • Bone Density Conservation Agents
  • Intestinal Neoplasms
  • Calcium
  • Leucovorin
  • Calcium, Dietary
  • Levoleucovorin
  • Calcium-Regulating Hormones and Agents
  • Molecular Mechanisms of Pharmacological Action
  • Capecitabine
  • Neoplasms
  • Carcinoma
  • Neoplasms by Histologic Type
  • Colonic Diseases
  • Neoplasms by Site
  • Colonic Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Colorectal Neoplasms
  • Oxaliplatin
  • Digestive System Diseases
  • Physiological Effects of Drugs
  • Digestive System Neoplasms
  • Oncology (Adult)
  • Fluorouracil
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Abdul Hai Mansoor, MD
Contact Information:
- Susan J Granat
-Susan.J.Granat@kpchr.org
-Central Interstate Medical Office


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