Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8
Conditions
Brief summary
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
Detailed description
PRIMARY OBJECTIVE: I. To estimate the percentage of participants that achieve complete clinical response. SECONDARY OBJECTIVES: I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT). II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS). EXPLORATORY OBJECTIVES: I. To characterize ctDNA clearance or non-clearance patterns during TNT. II. To correlate ctDNA levels with a participant's pathological features. III. To preliminary assess the prognostic performance of ctDNA levels in relation to participant's clinical outcome. OUTLINE: Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.
Interventions
PROCEDUREBiopsy
Undergo biopsy
PROCEDUREBiospecimen Collection
Undergo collection of blood and/or tissue samples
OTHERElectronic Health Record Review
Medical records are reviewed
Sponsors
OHSU Knight Cancer Institute
Natera, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged \>= 18 years * Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum: * T3N0M0 - T4bN2M0
Exclusion criteria
* Has radiologic evidence of distant metastases at the time of screening/enrollment * Has received prior treatment for their rectal adenocarcinoma * Requires or has received blood transfusion within 1 month of study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical response (cCR) | From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months. | cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive circulating tumor deoxyribonucleic acid (ctDNA) | From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years. | The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a watch and wait (W\&W) strategy. |
| Positive ctDNA after completing TNT | From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years | The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a W\&W strategy. |
| Rate of transabdominal surgery | Up to 3 years following completion of TNT | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. |
| Rate of pathological complete response (pCR) | From start of treatment until completion of surgery, up to 3 years. | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. |
| Rate of watch and wait strategy | Up to 3 years following completion of TNT | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. |
| Disease-free survival | Time between the date of surgery (or W&W population, the date of completing TNT) and the date of local or metastatic recurrence or death from any cause, assessed up to 3 years following completion of TNT | Will be estimated using the Kaplan-Meier method. |
| Overall survival | Time between the date of signed consent to the date of death from any cause, assessed up to 3 years following completion of TNT | Will be estimated using the Kaplan-Meier method. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdel Kardosh, M.D.,Ph.D.
OHSU Knight Cancer Institute
Outcome results
None listed