Rectal NeoplasmsPhase 2NCT01060007
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase 2 study testing External beam radiation, Oxaliplatin and Leucovorin in people with Rectal Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- External beam radiation, Oxaliplatin and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2014
- 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
- Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
- Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
- Karnofsky Performance Status at >60
- Laboratory criteria:
- Absolute neutrophil count >= 1.5 K
Show all 15Show fewer
- Platelets >= 100 K
- Total Bilirubin <= 2.0;
- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- Creatinine < 2.0
- Hemoglobin >= 8.0
- Informed consent signed
- Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
- Estimated longevity at least 12 months
- 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 any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
- Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
- Prior chemotherapy for colorectal cancer.
- Grade >= 2 peripheral neuropathy
- Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Read the detailed description
Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.
- Conditions
- Rectal Neoplasms
- Being tested
- External beam radiation, Oxaliplatin, Leucovorin, 5-FU, Capecitabine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiationRadiation
OxaliplatinDrug
Also called Eloxatin
LeucovorinDrug
5-FUDrug
Also called Fluorouracil, Efudex
CapecitabineDrug
Also called Xeloda
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiation followed by FOLFOX | Experimental | Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. Receives: Radiation: External beam radiation; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FU; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of T Stage Downstaging
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Measured: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Preoperative Gastrointestinal Morbidity
As measured by participants who experience grade 3 or higher gastrointestinal morbidity
Measured: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Secondary outcomes (7)
Incidence of Any Late Grade 3 or Higher Morbidity
Measured: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
Measured: 1 year (completion of all treatment)
Local Control
- Kaplan-Meier projections
- Local control = control of primary tumor
Measured: 30 months
Rate of Overall Control
Measured: 1 year
Rate of Locoregional Control
Measured: 1 year
Freedom From Disease Relapse
Kaplan-Meier projections.
Measured: 30 months
Determine Quality of Anorectal Function
Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2013
- Study completionSep 2014
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 NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag Parikh, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060007
- Sponsor's protocol ID
- 09-0696 / 201106272
- Status last verified
- Jan 2017
- First submitted
- 28 Jan 2010
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01060007
- Acronym / sponsor ID
- 09-0696 / 201106272
- Conditions
- Rectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Detailed description
Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiation followed by FOLFOX | Experimental | Radiation: External beam radiation, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FU, Drug: CapecitabineRadiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy proven adenocarcinoma of the rectum
- Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
- Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
- Karnofsky Performance Status at >60
- Laboratory criteria:
Key exclusion criteria (7 listed)
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
- Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
- Prior chemotherapy for colorectal cancer.
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 |
|---|---|---|
| External beam radiation | Radiation | Neoadjuvant radiation followed by FOLFOX |
| OxaliplatinAlso: Eloxatin | Drug | Neoadjuvant radiation followed by FOLFOX |
| Leucovorin | Drug | Neoadjuvant radiation followed by FOLFOX |
| 5-FUAlso: Fluorouracil, Efudex | Drug | Neoadjuvant radiation followed by FOLFOX |
| CapecitabineAlso: Xeloda | Drug | Neoadjuvant radiation followed by FOLFOX |
Primary outcome
Rate of T Stage Downstaging
Time frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Preoperative Gastrointestinal Morbidity
Time frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
As measured by participants who experience grade 3 or higher gastrointestinal morbidity
7 secondary outcomes
Incidence of Any Late Grade 3 or Higher Morbidity
Time frame: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
Time frame: 1 year (completion of all treatment)
Local Control
Time frame: 30 months
Rate of Overall Control
Time frame: 1 year
Rate of Locoregional Control
Time frame: 1 year
Freedom From Disease Relapse
Time frame: 30 months
Determine Quality of Anorectal Function
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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.
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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.
Parag Parikh, 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 External beam radiation, Oxaliplatin and Leucovorin in people with Rectal Neoplasms, 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 15 inclusion and 7 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 8 Mar 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 10 Feb 2015). 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 T Stage Downstaging (time frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)). 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 8 Mar 2017.