Mucinous Adenocarcinoma of the ColonNCT01934179
Telomere Length in Predicting Toxicity in Older Patients With Stage III-IV Colorectal Cancer Undergoing Chemotherapy
An observational study of Mucinous Adenocarcinoma of the Colon and Mucinous Adenocarcinoma of the Rectum, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Signet Ring Adenocarcinoma of the Colon
- What is being tested?
- cytology specimen collection procedure, laboratory biomarker analysis and questionnaire administration
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 11 Sep 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Cancer Center
Who may be able to join
- Both men and women of all races and ethnic groups are eligible for this trial
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is stage III or IV and has not been treated with systemic chemotherapy (biopsy of metastatic site not required if primary tumor biopsied and clinical scenario is consistent with metastatic disease)
- Patients must be deemed eligible for systemic chemotherapy with FOLFOX6 +/- bevacizumab at full standard doses
- For patient with metastatic disease, previous adjuvant chemotherapy is allowed as long it was completed at least 12 months prior to study enrollment and did not include oxaliplatin
- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
Show all 16Show fewer
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits, or creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Patients must demonstrate ability to understand and the willingness to sign a written informed consent document
- Patients must demonstrate ability to complete study questionnaires
- Patients must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- Male participants with female partners who are of childbearing potential must agree to use an acceptable and effective method of contraception
Who cannot join
- Patients with metastatic disease who have had adjuvant chemotherapy with oxaliplatin within 12 months of enrollment (single agent fluorouracil [5FU] or capecitabine is allowed) or radiotherapy within 4 weeks prior to entering the study
- Patients with known brain metastases should be excluded from this clinical trial
- Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection-requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known human immunodeficiency virus (HIV)-positive patients and those with known hepatitis B or C are excluded from the study
- Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Pilot Study Assessing the Correlation Between Telomere Length and Chemotherapy- Related Toxicity Among Early Stage and Metastatic Colorectal Patients Over the Age of 70
This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the relationship between pre-treatment telomere length (TL) and rate of grade 3 or higher adverse events occurring on front line leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX)-based chemotherapy among patients over the age of 70 with early stage or metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
- To evaluate the impact of the FOLFOX-based chemotherapy treatment on peripheral blood lymphocyte telomere length.
II. To evaluate the association between pre-treatment geriatric assessment tools scores, telomere length, and the incidence of chemotherapy related adverse events among older early stage or metastatic CRC patients.
TERTIARY OBJECTIVES:
- To evaluate the association between pre-treatment levels of serum interleukin-6 (IL-6), C-reactive protein (CRP) and D-dimer and incidence of chemotherapy related adverse events.
II. To evaluate the correlation between pre-treatment telomere length, levels of other biomarkers of aging (IL6, CRP, D-dimer), and rates of adverse events with FOLFOX-based chemotherapy.
OUTLINE:
Patients undergo blood sample collection for analysis via real-time polymerase chain reaction (PCR) at baseline, 3 months, and 6 months.
After completion of study, patients are followed up every 3 months for up to 2 years.
- Conditions
- Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer
- Being tested
- cytology specimen collection procedure, laboratory biomarker analysis, questionnaire administration
- Medical subject headings
- Colonic Neoplasms, 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
Undergo blood sample collection
laboratory biomarker analysisOther
Correlative studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (real-time PCR) | Patients undergo blood collection for analysis via real-time PCR at baseline, 3 months, and 6 months. Receives: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
TL
TL will be compared between participants experiencing at least 1 adverse event and those who experience none using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
Measured: Up to 6 months
Incidence of chemotherapy related grade 3 or higher adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Variance stabilizing and normalizing transformations will be applied to the data when appropriate. Descriptive statistics for participant characteristics, disease presentation, treatment related toxicity, treatment, duration of chemotherapy use, management of adverse events, and frequency of treatment discontinuation will be tabulated. TL will be compared between participants experiencing at least one adverse event and those who do not experience any adverse event using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
Measured: Up to 6 months
Secondary outcomes (1)
Change in TL after chemotherapy
Variance stabilizing and normalizing transformations will be applied to the data as and when appropriate. TL measured at 3 months and at 6 months after chemotherapy treatment will be compared to baseline (pre-treatment) using the Wilcoxon test or the paired t-test as appropriate. A type I error of 5% will be utilized to determine statistical significance. Pre- and post-treatment TL will be summarized using descriptive statistics.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion11 Sep 2015
- Study completion11 Sep 2015
Why it stopped: Low Accrual Rate
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 ColonStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 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
- Efrat Dotan, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934179
- Sponsor's protocol ID
- ERP-GI-049
- Other IDs
- NCI-2013-01415, 13-020, GI-049, P30CA006927
- Status last verified
- Feb 2018
- First submitted
- 29 Aug 2013
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing the Correlation Between Telomere Length and Chemotherapy- Related Toxicity Among Early Stage and Metastatic Colorectal Patients Over the Age of 70
- ClinicalTrials.gov ID
- NCT01934179
- Acronym / sponsor ID
- ERP-GI-049
- Conditions
- Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Accrual Rate
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2013
- Primary completion
- 11 Sep 2015 (actual)
- Study completion
- 11 Sep 2015 (actual)
- First posted
- 4 Sep 2013 (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 pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To determine the relationship between pre-treatment telomere length (TL) and rate of grade 3 or higher adverse events occurring on front line leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX)-based chemotherapy among patients over the age of 70 with early stage or metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
- To evaluate the impact of the FOLFOX-based chemotherapy treatment on peripheral blood lymphocyte telomere length.
II. To evaluate the association between pre-treatment geriatric assessment tools scores, telomere length, and the incidence of chemotherapy related adverse events among older early stage or metastatic CRC patients.
TERTIARY OBJECTIVES:
- To evaluate the association between pre-treatment levels of serum interleukin-6 (IL-6), C-reactive protein (CRP) and D-dimer and incidence of chemotherapy related adverse events.
II. To evaluate the correlation between pre-treatment telomere length, levels of other biomarkers of aging (IL6, CRP, D-dimer), and rates of adverse events with FOLFOX-based chemotherapy.
OUTLINE:
Patients undergo blood sample collection for analysis via real-time polymerase chain reaction (PCR) at baseline, 3 months, and 6 months.
After completion of study, patients are followed up every 3 months for up to 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (real-time PCR) | – | Other: cytology specimen collection procedure, Other: laboratory biomarker analysis, Other: questionnaire administrationPatients undergo blood collection for analysis via real-time PCR at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Cancer Center
Key inclusion criteria (16 listed)
- Both men and women of all races and ethnic groups are eligible for this trial
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is stage III or IV and has not been treated with systemic chemotherapy (biopsy of metastatic site not required if primary tumor biopsied and clinical scenario is consistent with metastatic disease)
- Patients must be deemed eligible for systemic chemotherapy with FOLFOX6 +/- bevacizumab at full standard doses
- For patient with metastatic disease, previous adjuvant chemotherapy is allowed as long it was completed at least 12 months prior to study enrollment and did not include oxaliplatin
- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry
Key exclusion criteria (6 listed)
- Patients with metastatic disease who have had adjuvant chemotherapy with oxaliplatin within 12 months of enrollment (single agent fluorouracil [5FU] or capecitabine is allowed) or radiotherapy within 4 weeks prior to entering the study
- Patients with known brain metastases should be excluded from this clinical trial
- Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection-requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known human immunodeficiency virus (HIV)-positive patients and those with known hepatitis B or C are excluded from the study
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 samplingUndergo blood sample collection | Other | Ancillary-correlative (real-time PCR) |
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-correlative (real-time PCR) |
| questionnaire administrationAncillary studies | Other | Ancillary-correlative (real-time PCR) |
Primary outcome
TL
Time frame: Up to 6 months
TL will be compared between participants experiencing at least 1 adverse event and those who experience none using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
Incidence of chemotherapy related grade 3 or higher adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 6 months
Variance stabilizing and normalizing transformations will be applied to the data when appropriate. Descriptive statistics for participant characteristics, disease presentation, treatment related toxicity, treatment, duration of chemotherapy use, management of adverse events, and frequency of treatment discontinuation will be tabulated. TL will be compared between participants experiencing at least one adverse event and those who do not experience any adverse event using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
1 secondary outcome
Change in TL after chemotherapy
Time frame: Baseline to 6 months
Results and safety
The study was stopped early (reason given: Low Accrual Rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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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.
Efrat Dotan 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 Colon and Mucinous Adenocarcinoma of the Rectum, 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 16 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Feb 2018. 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 was stopped early (reason given: Low Accrual Rate). Results are not available in the source record.
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?
TL (time frame: Up to 6 months). 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 7 Feb 2018.