NCT03749083 - A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer | Crick

Overview

In this research study, the investigators are looking to see if the circulating tumor DNA (genetic material), also known as ctDNA, in the blood will help them predict whether the participant's cancer will come back.

In this research study, the investigator are performing blood draws to see if the presence or absence of circulating tumor DNA (ctDNA), the genetic material in the participant's cancer's cells, will help the investigators predict whether the participant's cancer will come back or not.

Study Type

OBSERVATIONAL

Conditions

Gastrointestinal Malignancies

Interventions

The Functional Assessment of Cancer Therapy- ColorectalOTHER

The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have achieved a clinical complete response (cCR) within 3 months of last therapy - defined as absence of residual ulceration, mass or mucosal irregularity at endoscopic assessment - following neoadjuvant therapy with chemoradiation or chemotherapy followed by radiation for stage I, II, or III non-metastatic rectal cancer. (Whitening of the mucosa with presence of telangiectasia will be accepted as cCR.) * Participants must have original tumor tissue (formalin-fixed, paraffin-embedded specimens) available for analysis * Participants must be 18 years of age or older. * Participants must be able to understand and willing to sign a written informed consent document. * Participants must have received long course chemoradiation to 40-54 Gy. * Participants must have received at least 4 cycles of FOLFOX * Participant must be no more than 3 months past the conclusion of initial chemoradiation of rectal cancer (i.e., end of chemoradiation). Exclusion Criteria: * Participants may not have any other organ cancer evident at the time of enrollment. * Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.

Locations (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women Hospital

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

Outcomes

Primary Outcomes

One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA

Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.

Time frame: 1 year

Secondary Outcomes

Local recurrence rate at any time up to 5 years in patients who have achieved a clinical complete response after rectal cancer treatment but who test positive for circulating tumor DNA at study entry

Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.

Time frame: 5 years

Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets

Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.

Time frame: 5 years

Median EORTC QLQ-CR29 Score

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for Colorectal cancer(CR) 29 item questionnaire. The survey will be given at baseline, 6, 12, and 24 months. Results will be reported as the median score for each question. A score of 1 represents 'Not at All' and 4 represents 'Very Much'.