Rectal CancerNCT01835925
Rectal Cancer Consortium
An observational study of Rectal Cancer, run by Brown University at 2 sites in United States.
Trial summary
The purpose of this study is to study which genes are abnormal in rectal cancer and see if this predicts how well chemotherapy and radiation will reduce the size of cancer and whether cancer recurs after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Tissue specimen
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Apr 2014
- 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: Patients with stage II or III rectal cancer (adenocarcinoma)
Who may be able to join
- Patients must have histologically proven adenocarcinoma of the rectum with no evidence of distant metastases.
- The tumor must be clinically Stage II (T3-4 N0) or III (T1-4 N1-2).
- Patients must have no evidence of distant metastases including liver metastases, peritoneal seeding, or inguinal lymphadenopathy.
- Patients who completed or are actively enrolled in the CONTRE study and patients undergoing treatment for rectal cancer following the TNT (Total Neoadjuvant Treatment) format (see below) for whom sufficient tissue is available for the required research analyses may be enrolled in this study retroactively.
- For those who have not yet received treatment for rectal adenocarcinoma, these patients must not have received prior chemotherapy or pelvic radiation for rectal cancer, or prior pelvic radiation for any other malignancy that would prevent the patient from receiving the required radiation treatments for this study.
- Patients must not have an active concurrent invasive malignancy other than non-melanoma skin cancers. Patients with malignancies diagnosed within 5 years prior to randomization which have been effectively treated and are deemed to be at low risk for recurrence are eligible.
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- Patients must be > 18 years of age, ECOG (performance status) 0-1.
- ANC (absolute neutrophil count) >1,500/µl, platelets >100,000/µl, total bilirubin <2.0 mg/dl or direct bilirubin <1.0 mg/dl, alkaline phosphatase <3xULN, ALT <3xULN, creatinine <1.5xULN.
- Signed informed consent; able to comply with study and/or follow- up procedures
- Peripheral neuropathy < grade 1.
- The intention of the treating physicians is to administer Total Neoadjuvant Treatment as per the suggested treatment guidelines in section 4 and section 5 or as per standard institutional policies.
Who cannot join
- Evidence of metastatic disease.
- Rectal cancers other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, cloacogenic carcinoma, etc.
- Pregnancy or lactation at the time of proposed randomization. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraception.
- Synchronous invasive colon cancer.
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from receiving any chemotherapy treatment option or would prevent required follow-up.
- Patients with active inflammatory bowel disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 or other serious medical illness which might limit the ability of the patient to receive protocol therapy.
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- Known hypersensitivity to 5-fluorouracil or oxaliplatin
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- Insufficient tumor tissue available for the required genomic analyses and patient unable or unwilling to undergo repeat examination and biopsies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02903
About this study
Official title: Rectal Cancer Consortium: BrUOG 285: A Comprehensive Program to Identify Therapeutic Targets and Develop Targeted Agents for Testing With Total Neoadjuvant Treatment for Stage II-III Rectal Cancer BrUOG= Brown University Oncology Research Group
The purpose of this study is to study which genes are abnormal in rectal cancer and see if this predicts how well chemotherapy and radiation will reduce the size of cancer and whether cancer recurs after surgery.
Read the detailed description
Specific gene mutations have become targets for specific therapies. For example lung adenocarcinomas with an EGFR (epidermal growth factor receptor) mutation can be targeted with an EGFR tyrosine kinase inhibitor achieve striking and durable responses and improved survival. Another example is the identification of the echinoderm microtubule-associated protein-like 4/anaplastic lymphoma kinase (ALK) gene fusions which have led to significant therapeutic gains in the small percentage of patients with lung adenocarcinoma whose cancers exhibit this mutation. Specific mutations have been found in colon cancer and specific drugs targeting these gene alterations are in development. As future therapeutic protocols specific for these mutations are developed, patients who agree may be notified of their eligibility for these studies.
The aims of this study are to link mutational analyses with clinical outcome. It is recommended that patients receive 8 cycles of mFOLFOX6 (modified FOLFOX) and 50.4 Gy radiation with concurrent fluoropyrimidine.
- Conditions
- Rectal Cancer
- Being tested
- Tissue specimen
- Keywords
- adenocarcinoma of rectum, rectal cancer, stage II, stage III
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue specimenGenetic
| Study group | Role | What they receive |
|---|---|---|
| Tissue specmien | Not described Receives: Genetic: Tissue specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor tissue to predict likelihood of achieving pathologic complete response post standard treatment.
Measured: baseline
Secondary outcomes (1)
Tumor tissue results with clinical outcome post standard treatment. .
Measured: annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- Howard Safran, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835925
- Sponsor's protocol ID
- 285
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2013
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer Consortium: BrUOG 285: A Comprehensive Program to Identify Therapeutic Targets and Develop Targeted Agents for Testing With Total Neoadjuvant Treatment for Stage II-III Rectal Cancer BrUOG= Brown University Oncology Research Group
- ClinicalTrials.gov ID
- NCT01835925
- Acronym / sponsor ID
- 285
- Conditions
- Rectal Cancer
- Keywords
- adenocarcinoma of rectum, rectal cancer, stage II, stage III
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Apr 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.
The purpose of this study is to study which genes are abnormal in rectal cancer and see if this predicts how well chemotherapy and radiation will reduce the size of cancer and whether cancer recurs after surgery.
Detailed description
Specific gene mutations have become targets for specific therapies. For example lung adenocarcinomas with an EGFR (epidermal growth factor receptor) mutation can be targeted with an EGFR tyrosine kinase inhibitor achieve striking and durable responses and improved survival. Another example is the identification of the echinoderm microtubule-associated protein-like 4/anaplastic lymphoma kinase (ALK) gene fusions which have led to significant therapeutic gains in the small percentage of patients with lung adenocarcinoma whose cancers exhibit this mutation. Specific mutations have been found in colon cancer and specific drugs targeting these gene alterations are in development. As future therapeutic protocols specific for these mutations are developed, patients who agree may be notified of their eligibility for these studies.
The aims of this study are to link mutational analyses with clinical outcome. It is recommended that patients receive 8 cycles of mFOLFOX6 (modified FOLFOX) and 50.4 Gy radiation with concurrent fluoropyrimidine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue specmien | – | Genetic: Tissue specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage II or III rectal cancer (adenocarcinoma)
Key inclusion criteria (11 listed)
- Patients must have histologically proven adenocarcinoma of the rectum with no evidence of distant metastases.
- The tumor must be clinically Stage II (T3-4 N0) or III (T1-4 N1-2).
- Patients must have no evidence of distant metastases including liver metastases, peritoneal seeding, or inguinal lymphadenopathy.
- Patients who completed or are actively enrolled in the CONTRE study and patients undergoing treatment for rectal cancer following the TNT (Total Neoadjuvant Treatment) format (see below) for whom sufficient tissue is available for the required research analyses may be enrolled in this study retroactively.
- For those who have not yet received treatment for rectal adenocarcinoma, these patients must not have received prior chemotherapy or pelvic radiation for rectal cancer, or prior pelvic radiation for any other malignancy that would prevent the patient from receiving the required radiation treatments for this study.
Key exclusion criteria (9 listed)
- Evidence of metastatic disease.
- Rectal cancers other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, cloacogenic carcinoma, etc.
- Pregnancy or lactation at the time of proposed randomization. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraception.
- Synchronous invasive colon cancer.
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from receiving any chemotherapy treatment option or would prevent required follow-up.
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 |
|---|---|---|
| Tissue specimen | Genetic | Tissue specmien |
Primary outcome
Tumor tissue to predict likelihood of achieving pathologic complete response post standard treatment.
Time frame: baseline
1 secondary outcome
Tumor tissue results with clinical outcome post standard treatment. .
Time frame: annually for 5 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 1 May 2014.
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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.
Howard Safran, MD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Brown University at 2 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 11 inclusion and 9 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 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Tumor tissue to predict likelihood of achieving pathologic complete response post standard treatment. (time frame: baseline). 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 1 May 2014.