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

NCT03749083 | Withdrawn

• 1 other identifier: 18-304
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastrointestinal Malignancies

Keywords

Gastrointestinal Malignancies

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (7)

• 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

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

  5 years

• Median EORTC QLQ-CR29 Score

  Baseline, 6 months, 12 months, 24 months

• Median SF-12 Health Survey Score

  Baseline, 6 months, 12 months, 24 months

• Median LARS Score

  Baseline, 6 months, 12 months, 24 months

Study Arms (1)

Tumor Sequencing

* Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal * Blood for circulating tumor DNA will be collected

Other: The Functional Assessment of Cancer Therapy- Colorectal

Interventions

The Functional Assessment of Cancer Therapy- Colorectal OTHER

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

Tumor Sequencing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective, observational, non-interventional study will enroll patients who have achieved a clinical complete response after treatment for rectal cancer and are undergoing standard surveillance.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Clinical Genomics: collaborator

Study Sites (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women Hospital

Boston, Massachusetts, 02215, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02459, United States

Location

Study Officials

• Theodore S Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 21, 2018
• Study Start: December 31, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2024
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)