Rectal CarcinomaPhase 2NCT00682786
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
A Phase 2 study testing 5FU, Radiation and Surgery of resectable lesions in people with Rectal Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- 5FU, Radiation and Surgery of resectable lesions
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Biopsy proven adenocarcinoma of the rectum
- Lesion evaluated by surgeon and found to be resectable
- Stage T3 or T4 disease on radiography or ultrasound
- Karnofsky Performance Status at >60
- Laboratory criteria:
- Absolute neutrophil count >= 1.5 K
Show all 12Show fewer
- Platelets >= 100 K
- Total Bilirubin <= 2.0;
- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- Creatinine < 2.0
- Informed consent signed
- Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Who cannot join
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
- Patients with known allergy to 5-fluorouracil or irinotecan
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.
- Conditions
- Rectal Carcinoma
- Being tested
- 5FU, Radiation, Surgery of resectable lesions, Irinotecan
- Keywords
- rectal, rectum, cancer, carcinoma
- Medical subject headings
- Rectal Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5FUDrug
Also called Fluorouracil, 5-fluorouracil
RadiationRadiation
Surgery of resectable lesionsProcedure or surgery
IrinotecanDrug
Also called Camptosar
| Study group | Role | What they receive |
|---|---|---|
| Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Experimental | Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. Receives: Drug: 5FU; Radiation: Radiation; Procedure: Surgery of resectable lesions |
| Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Experimental | Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. Receives: Drug: 5FU; Radiation: Radiation; Procedure: Surgery of resectable lesions; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tumor Downstaging Compared With Historical Controls.
Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.
Historical studies demonstrate a DS rate of 45%.
Measured: 1 year after enrollment
Secondary outcomes (3)
Complete Response Rates
Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).
Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).
pCR rate of historical controls is 8%-14%.
Measured: 1 year after enrollment
Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
The questionnaire is encouraged but not required.
Measured: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Determine Patient Fears and Expectations of Pharmacogenetics.
The questionnaire is encouraged but not required.
Measured: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startOct 2002
- Primary completionDec 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Tan, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682786
- Sponsor's protocol ID
- 02-0561
- Status last verified
- Sep 2017
- First submitted
- 11 Apr 2008
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT00682786
- Acronym / sponsor ID
- 02-0561
- Conditions
- Rectal Carcinoma
- Keywords
- rectal, rectum, cancer, carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Experimental | Drug: 5FU, Radiation: Radiation, Procedure: Surgery of resectable lesionsRadiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Experimental | Drug: 5FU, Radiation: Radiation, Procedure: Surgery of resectable lesions, Drug: IrinotecanRadiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Biopsy proven adenocarcinoma of the rectum
- Lesion evaluated by surgeon and found to be resectable
- Stage T3 or T4 disease on radiography or ultrasound
- Karnofsky Performance Status at >60
- Laboratory criteria:
Key exclusion criteria (4 listed)
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
- Patients with known allergy to 5-fluorouracil or irinotecan
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 |
|---|---|---|
| 5FUAlso: Fluorouracil, 5-fluorouracil | Drug | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4), Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) |
| Radiation | Radiation | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4), Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) |
| Surgery of resectable lesions | Procedure or surgery | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4), Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) |
| IrinotecanAlso: Camptosar | Drug | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) |
Primary outcome
Rate of Tumor Downstaging Compared With Historical Controls.
Time frame: 1 year after enrollment
Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%.
3 secondary outcomes
Complete Response Rates
Time frame: 1 year after enrollment
Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
Time frame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Determine Patient Fears and Expectations of Pharmacogenetics.
Time frame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Related trials for Rectal Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
CBX-12 for the Treatment of Metastatic Chemotherapy-Refractory Microsatellite Stable Colorectal Cancer
Metastatic Mismatch Repair Proficient Colorectal Carcinoma, Refractory Mismatch Repair Proficient Colorectal Carcinoma
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.
Benjamin Tan, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5FU, Radiation and Surgery of resectable lesions in people with Rectal Carcinoma, run by Washington University School of Medicine 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 12 inclusion and 4 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 6 Oct 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Tumor Downstaging Compared With Historical Controls. (time frame: 1 year after enrollment). 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 6 Oct 2017.