Gastrointestinal MalignanciesNCT03749083
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
An observational study of Gastrointestinal Malignancies, run by Massachusetts General Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Malignancies
- What is being tested?
- The Functional Assessment of Cancer Therapy- Colorectal
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Dec 2019to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women Hospital
Boston, Massachusetts, 02215
Newton-Wellesley Hospital
Newton, Massachusetts, 02459
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Malignancies
- Being tested
- The Functional Assessment of Cancer Therapy- Colorectal
- Keywords
- Gastrointestinal Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: The Functional Assessment of Cancer Therapy- Colorectal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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'.
Measured: Baseline, 6 months, 12 months, 24 months
Median SF-12 Health Survey Score
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.
Measured: Baseline, 6 months, 12 months, 24 months
Median LARS Score
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.
Measured: Baseline, 6 months, 12 months, 24 months
Median FIQOL Score
Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status.
Measured: Baseline, 6 months, 12 months, 24 months
Median Fecal Incontinence Severity Index (FISI) score
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.
Measured: Baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start31 Dec 2019 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MalignanciesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Genomics
- Responsible party
- Principal investigator, Theodore Sunki Hong, Massachusetts General Hospital
- Investigators
- Theodore S Hong, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749083
- Sponsor's protocol ID
- 18-304
- Status last verified
- Jul 2019
- First submitted
- 15 Nov 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03749083
- Acronym / sponsor ID
- 18-304
- Conditions
- Gastrointestinal Malignancies
- Keywords
- Gastrointestinal Malignancies
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Clinical Genomics
- Study start
- 31 Dec 2019 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Sequencing | – | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Functional Assessment of Cancer Therapy- ColorectalThe Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses. | Other | Tumor Sequencing |
Primary outcome
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.
7 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
Time frame: 5 years
Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets
Time frame: 5 years
Median EORTC QLQ-CR29 Score
Time frame: Baseline, 6 months, 12 months, 24 months
Median SF-12 Health Survey Score
Time frame: Baseline, 6 months, 12 months, 24 months
Median LARS Score
Time frame: Baseline, 6 months, 12 months, 24 months
Median FIQOL Score
Time frame: Baseline, 6 months, 12 months, 24 months
Median Fecal Incontinence Severity Index (FISI) score
Time frame: Baseline, 6 months, 12 months, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore S Hong, MD principal investigator
Massachusetts General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Malignancies, run by Massachusetts General Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.