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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Malignancies
- Sponsor
- Massachusetts General Hospital
- Locations
- 4
- Primary Endpoint
- One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Theodore Sunki Hong
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA
Time Frame: 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 Outcomes
- Median FIQOL Score(Baseline, 6 months, 12 months, 24 months)
- 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)
- Median EORTC QLQ-CR29 Score(Baseline, 6 months, 12 months, 24 months)
- Median Fecal Incontinence Severity Index (FISI) score(Baseline, 6 months, 12 months, 24 months)
- Median SF-12 Health Survey Score(Baseline, 6 months, 12 months, 24 months)
- Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets(5 years)
- Median LARS Score(Baseline, 6 months, 12 months, 24 months)