Behaviors and Mental Disorders

All Conditions

Neoplasms

Digestive System Diseases

Financial Stress

Rectal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Stress, Psychological

Behavioral Symptoms

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

Quality-of-Life Assessment

Questionnaire Administration

Sheetal Kircher

This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.

PRIMARY OBJECTIVES:

I. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

SECONDARY OBJECTVIES:

I. Evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

III. Evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines.

IV. Evaluate the change of quality-of-life outcome (QoL) from baseline to 12 months and its association with predictors.

V. Evaluate the change in level of self-reported financial burden from baseline to 12 months using alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer \[EORTC\] questionnaire \[Q\]30).

OUTLINE:

Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment

Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent

Will calculate the difference of Comprehensive Score for Financial Toxicity (COST) measurements from baseline to 12-month follow up for the completers who provide data at both time points, and use the paired t-test to assess if the mean difference is significantly different from zero. In case the data are not normally distributed, nonparametric methods (e.g., Wilcoxon signed-rank test) will be used instead to assess the difference. In addition, linear regression models with the change of COST from baseline to 12-month follow up as the response variable will be fit to investigate the impact of other factors, including demographics variables (e.g., age, sex, marital status), clinical variables (e.g., stage of disease, malignancy type, chemotherapy status), baseline questionnaire variables (e.g., self-efficacy,). The three-level treatment status (intravenous \[IV\] chemotherapy, chemotherapy without IV, and no chemotherapy) will also be evaluated as a predictor.

Will evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. Will be assessed by Consumer Based Cancer Care Value Index (CCVI). For the continuous item variable, will conduct the paired t test to examine the difference if the distribution is normal. If not normally distributed, Wilcoxon signed rank test will be used. For the categorical item variable, the paired proportion test (e.g., McNemar test) will be used instead. The association between CCVI and COST measures will be evaluated using the Pearson or Spearman correlation coefficient.

Will be assessed by Work Productivity and Activity Impairment Questionnaire, Work Ability Index, and Work after cancer survey. If the distributions are normal, will conduct the paired t tests to examine the differences of these variables. If not normally distributed, Wilcoxon signed rank tests will be used. The association with COST measures will be evaluated using the Pearson or Spearman correlation coefficients.

Will evaluate long term outcomes at 24 months after diagnosis for adherence to clinical follow-up guidelines. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Will evaluate long term outcomes at 24 months after diagnosis for financial burden. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time and also the effects of cancer type, stage, treatment plan and demographics, etc. on financial burden. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Will evaluate long term outcomes at 24 months after diagnosis for employment limitations. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Will evaluate the change of QoL from baseline to 12 months and its association with predictors. Will be evaluated by Functional Assessment of Cancer Therapy-General.

Will use alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer Questionnaire 30).

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Adenocarcinoma

Antineoplastic Agents

Micronutrients

Hematinics

Bone Density Conservation Agents

Vitamins

Capecitabine

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Calcium

Folic Acid

Calcium, Dietary

Vitamin B Complex

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Folinic Acid

Folate

Vitamin B9

Patients are assigned to 1 of 2 groups.

GROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin IV over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity at the discretion of the investigator.

GROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.

Leucovorin Calcium

Patient Observation

Van K Morris

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.

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.

ARM I (BLOOD STORED AND TESTED FOR ctDNA LATER): Patients undergo active surveillance.

ARM II (BLOOD TESTED FOR ctDNA AT BASELINE): Patients are assigned to 1 of 2 groups.

GROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin intravenously (IV) over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

GROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.

After completion of study treatment, patients are followed up at 12 months and then every 6 months for 2 years.

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)

Will be associated with time to event outcomes (RFS, OS, and TTR) by treatment received.

Will be associated with TTR. Will be determined using a ctDNA assay in patients with resected stage IIA colon cancer.

A two by two contingency table of clearance by treatment arm will be created. The one-sided Fisher exact p-value will be used to determine futility based on the rule specified. Degenerate tables where the Fisher p-value cannot be calculated (no patients clear on either arm or all patients clear on both arms) will count as a failure and a recommendation for early termination.

RFS will be compared by treatment arm using the logrank test with no stratification in the intent to treat (ITT) cohort. Kaplan Meier curves will be computed to describe the distribution of time to event. A summary hazard ratio and associated confidence interval will be computed from a Cox model with treatment arm as the only covariate.

According to ctDNA marker status and treatment. Kaplan Meier analyses to describe the distribution of time to event for each marker-treatment combination.

According to ctDNA marker status and treatment. Kaplan Meier analyses to describe the distribution of time to event for each marker-treatment combination. The unstratified logrank test will be used to compare treatments for patients ?ctDNA positive? at baseline and a Cox model will estimate the hazard ratio.

The duration of chemotherapy will be categorized as none, less than 3 months, and at least 3 months by treatment arm and baseline ctDNA status. Arms will be compared by a chi square test within each baseline ctDNA status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment	NCT03516942	Stage I Colon C... Stage I Rectal ... Stage II Colon ... Stage II Rectal... Stage IIA Colon... Stage IIA Recta... Stage IIB Colon... Stage IIB Recta... Stage IIC Colon... Stage IIC Recta... Stage III Colon... Stage III Recta... Stage IIIA Colo... Stage IIIA Rect... Stage IIIB Colo... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Rect...	Quality-of-Life... Questionnaire A...	18 Years -	Eastern Cooperative Oncology Group
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery	NCT04068103	Colon Adenocarc... Stage IIA Colon...	Capecitabine Fluorouracil Leucovorin Leucovorin Calc... Oxaliplatin Patient Observa...	18 Years -	NRG Oncology
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery	NCT04068103	Colon Adenocarc... Stage IIA Colon...	Capecitabine Fluorouracil Leucovorin Leucovorin Calc... Oxaliplatin Patient Observa...	18 Years -	NRG Oncology

Spots Global Cancer Trial Database for stage iia colon cancer ajcc v8