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
- Conditions
- Gastrointestinal Malignancies
- Interventions
- Other: The Functional Assessment of Cancer Therapy- Colorectal
- Registration Number
- NCT03749083
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tumor Sequencing The Functional Assessment of Cancer Therapy- Colorectal * Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal * Blood for circulating tumor DNA will be collected
- Primary Outcome Measures
Name Time Method One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA 1 year 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.
- Secondary Outcome Measures
Name Time Method Median FIQOL Score Baseline, 6 months, 12 months, 24 months Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status.
Median Fecal Incontinence Severity Index (FISI) score Baseline, 6 months, 12 months, 24 months The FISI measures incontinence for gas, mucus, liquid stool,and solid stool. The survey assesses the number of times per day that the participant experiences incontinence for gas, mucus, liquid stool,and solid stool. Higher scores represent a higher degree of fecal incontinence.
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 5 years 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.
Median EORTC QLQ-CR29 Score Baseline, 6 months, 12 months, 24 months 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'.
Median SF-12 Health Survey Score Baseline, 6 months, 12 months, 24 months The SF-12 is a 12 item validated questionnaire that assesses a participants view of their health. Scores will be normalized on a 100 point scale with higher scores representing better health.
Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets 5 years 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.
Median LARS Score Baseline, 6 months, 12 months, 24 months The Low Anterior Resection Syndrome (LARS) Score is used to assess bowel dysfunction. The survey is assessed on a scale of 0-42 points, with a higher score indicating worse bowel dysfunction.
Trial Locations
- Locations (4)
Brigham and Women Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States