Mucinous Adenocarcinoma of the RectumNCT02132858
Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation
An observational study of Mucinous Adenocarcinoma of the Rectum and Recurrent Rectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucinous Adenocarcinoma of the Rectum, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Rectum
- What is being tested?
- cytology specimen collection procedure and laboratory biomarker analysis
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic
Who may be able to join
- Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0
- Radiologically measurable or clinically evaluable disease
- Provide informed written consent
- Willing to return to enrolling medical site for all study assessments
Who cannot join
- Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years)
- Any prior pelvic radiation
- Patients who are at high risk of complications from temporarily discontinuing anticoagulation for rectal cancer biopsies
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the tumor-specific mutation(s) detected using the CancerCode™ mutation panel as a predictor of pathologic response to chemoradiation for patients with rectal adenocarcinoma undergoing chemoradiation.
SECONDARY OBJECTIVES:
- To assess the feasibility of utilizing biopsy specimens from locally advanced rectal adenocarcinoma to perform CancerCode™ mutation panel genetic testing.
II. To assess disease-free survival (DFS) and overall survival (OS) of patients treated on study.
III. To collect pilot data regarding the clonal heterogeneity of rectal adenocarcinoma, and the relationship of this heterogeneity with treatment response.
IV. To evaluate the treatment response utilizing multiple fludeoxyglucose F 18-positron emission tomography (FDG-PET) parameters including heterogeneity and textural features as an exploratory study.
OUTLINE:
Patients undergo collection of blood and tissue samples for analysis via sequencing.
After completion of study, patients are followed up every 3 months for 3 years.
- Conditions
- Mucinous Adenocarcinoma of the Rectum, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Rectum, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer
- Being tested
- cytology specimen collection procedure, laboratory biomarker analysis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
Also called cytologic sampling
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (genetic mutation analysis) | Patients undergo collection of blood and tissue samples for analysis via sequencing. Receives: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the randomly chosen samples that are successfully sequenced
If >= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible.
Measured: Up to 3 years
Tumor response measured using the tumor regression grading system
Whether mutations in any gene on the CancerCode mutation panel are associated with tumor response will be assessed. In each sample, the presence or absence of mutations (0/1) for each gene on the panel will be evaluated. Each gene will be tested separately for its association with tumor response using a two-sample Mann-Whitney-Wilcoxon test with a type-I error of 0.05 for a two-sided test.
Measured: Up to 3 years
Secondary outcomes (1)
Tumor heterogeneity in patients with partial response to radiation
Whether there are differences in the mutation profiles in the 4 tumor samples will be assessed, with differences being considered evidence of possible heterogeneity.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJul 2014
- Primary completion8 Apr 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucinous Adenocarcinoma of the RectumStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132858
- Sponsor's protocol ID
- CGI-066
- Other IDs
- NCI-2014-00719, CGI-066, P30CA006927
- Status last verified
- May 2024
- First submitted
- 6 May 2014
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
- ClinicalTrials.gov ID
- NCT02132858
- Acronym / sponsor ID
- CGI-066
- Conditions
- Mucinous Adenocarcinoma of the Rectum, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Rectum, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 7 May 2014 (estimated)
- 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.
This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the tumor-specific mutation(s) detected using the CancerCode™ mutation panel as a predictor of pathologic response to chemoradiation for patients with rectal adenocarcinoma undergoing chemoradiation.
SECONDARY OBJECTIVES:
- To assess the feasibility of utilizing biopsy specimens from locally advanced rectal adenocarcinoma to perform CancerCode™ mutation panel genetic testing.
II. To assess disease-free survival (DFS) and overall survival (OS) of patients treated on study.
III. To collect pilot data regarding the clonal heterogeneity of rectal adenocarcinoma, and the relationship of this heterogeneity with treatment response.
IV. To evaluate the treatment response utilizing multiple fludeoxyglucose F 18-positron emission tomography (FDG-PET) parameters including heterogeneity and textural features as an exploratory study.
OUTLINE:
Patients undergo collection of blood and tissue samples for analysis via sequencing.
After completion of study, patients are followed up every 3 months for 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (genetic mutation analysis) | – | Other: cytology specimen collection procedure, Other: laboratory biomarker analysisPatients undergo collection of blood and tissue samples for analysis via sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic
Key inclusion criteria (4 listed)
- Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0
- Radiologically measurable or clinically evaluable disease
- Provide informed written consent
- Willing to return to enrolling medical site for all study assessments
Key exclusion criteria (3 listed)
- Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years)
- Any prior pelvic radiation
- Patients who are at high risk of complications from temporarily discontinuing anticoagulation for rectal cancer biopsies
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 |
|---|---|---|
| cytology specimen collection procedureAlso: cytologic samplingCorrelative studies | Other | Ancillary-Correlative (genetic mutation analysis) |
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-Correlative (genetic mutation analysis) |
Primary outcome
Proportion of the randomly chosen samples that are successfully sequenced
Time frame: Up to 3 years
If >= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible.
Tumor response measured using the tumor regression grading system
Time frame: Up to 3 years
Whether mutations in any gene on the CancerCode mutation panel are associated with tumor response will be assessed. In each sample, the presence or absence of mutations (0/1) for each gene on the panel will be evaluated. Each gene will be tested separately for its association with tumor response using a two-sample Mann-Whitney-Wilcoxon test with a type-I error of 0.05 for a two-sided test.
1 secondary outcome
Tumor heterogeneity in patients with partial response to radiation
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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.
Joshua Meyer principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucinous Adenocarcinoma of the Rectum and Recurrent Rectal Cancer, run by Fox Chase Cancer Center at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of the randomly chosen samples that are successfully sequenced (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 2 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.