Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Carcinoma

Adenocarcinoma

Neoplastic Cells, Circulating

Rectal Neoplasms

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.

Biospecimen Collection

Yi-Qian N You

This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.

PRIMARY OBJECTIVES:

I. To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.

II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.

III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.

OUTLINE:

Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.

Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

Circulating Tumor Elements in Patients With Rectal Cancer

The proportion of patients with any CTC will be calculated with a 95% confidence interval (CI). Additionally, the actual CTC count will be plotted with a box-plot. Proportions of patients with 2 or more, and 3 or more CTCs will be calculated. Will also explore correlations between the presence of 1 or more CTC and primary tumor characteristics using Chi-Squared or Fischer's exact tests as appropriate.

A McNemar's test will be used to test whether neoadjuvant therapy (NEO) provided any improvement in the proportion of patients with any CTC. The CTC counts at baseline versus 8 weeks after completion of treatment will be compared with a paired t-test.

M.D. Anderson Cancer Center

Colonic Neoplasms

Colonic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bevacizumab

Irinotecan

Antibodies

Antibodies, Monoclonal

Trifluridine

Immunoglobulins

Hydroquinone

10-hydroxycamptothecin

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Patients receive irinotecan IV over 90 minutes and bevacizumab IV over 10 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride PO BID on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Trifluridine and Tipiracil Hydrochloride

Christos Fountzilas, MD

This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.

PRIMARY OBJECTIVE:

I. Determine the median progression free survival (PFS) benefit of leucovorin calcium, 5-fluorouracil, and irinotecan (FOLFIRI) naive patients treated with trifluridine and tipiracil hydrochloride (TAS-102) + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab.

SECONDARY OBJECTIVE:

I. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile.

OUTLINE:

Patients receive irinotecan intravenously (IV) over 90 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years.

TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study

A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-Treated Metastatic Colorectal Cancer (TABAsCO)

Will be assessed via the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guidelines. The PFS will be summarized using standard Kaplan-Meier methods, where estimates of the median PFS and 6/12-month PFS rates will be obtained with 90% confidence intervals.

ill be tabulated based upon RECIST v1.1 criteria. Will be summarized using frequencies and relative frequencies. Using Jeffrey's prior method, a 90% confidence interval about the true ORR will be obtained for each treatment group.

OS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival and 12-month rates are obtained with 90% confidence intervals

DSS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival and 12-month rates are obtained with 90% confidence intervals.

easured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and recorded to objectively measure toxicities of the combination therapy. Treatment related adverse events (as per CTCAE v5.0) will be summarized by grade using frequencies and

National Comprehensive Cancer Network

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer	NCT02874885	Locally Advance... Metastatic Rect... Rectosigmoid Ad... Recurrent Recta... Recurrent Recto... Stage III Recta... Stage IIIA Rect... Stage IIIB Rect... Stage IIIC Rect... Stage IV Rectal... Stage IVA Recta... Stage IVB Recta... Stage IVC Recta...	Biospecimen Col...	18 Years -	M.D. Anderson Cancer Center
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study	NCT04109924	Advanced Colore... Metastatic Colo... Metastatic Rect... Recurrent Colon... Recurrent Color... Recurrent Recta... Stage III Colon... Stage III Color... Stage III Recta... Stage IIIA Colo... Stage IIIA Colo... Stage IIIB Colo... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Colo... Stage IV Colon ... Stage IVA Color... Stage IVA Recta... Stage IVB Colon... Stage IVB Color... Stage IVB Recta... Stage IVC Colon... Stage IVC Color... Stage IVC Recta... Unresectable Co... Unresectable Co... Unresectable Re...	Irinotecan Bevacizumab Trifluridine an...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for recurrent rectal adenocarcinoma