Rectal NeoplasmsPhase 2PROCTFULNCT00263029
Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine and Radiotherapy in people with Rectal Neoplasms, run by Sanofi.
Trial summary
The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Oxaliplatin, Capecitabine and Radiotherapy
- 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
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Mar 2007
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status score 0-1.
- Chemo-naïve patients.
- Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
- Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
- Adequate haematological, renal and liver functions as follows:
- ANC > 3000ml
Show all 10Show fewer
- Platelet count > 100,000 ml
- Urea \& Serum Creatinine < 1.5 X upper limit of normal value
- Total serum bilirubin < 1.5 X upper limit of normal value
- ALT \& AST < 3 X upper limit of normal value
Who cannot join
- Prior chemotherapy.
- Documented allergy to oxaliplatin or capecitabine.
- Prior radiotherapy to pelvis.
- Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
- Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
- Currently participating into another clinical trial with any investigational drug in the previous 30 days.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.
- Conditions
- Rectal Neoplasms
- Being tested
- Oxaliplatin, Capecitabine, Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
CapecitabineDrug
500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart
RadiotherapyRadiation
Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
Measured: 3-years disease- free-survival or 3-years overall survival
Secondary outcomes (1)
Adverse events collection
Measured: From the signature of the informed consent up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startJun 2002
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iris CHAN, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263029
- Sponsor's protocol ID
- L_8479
- Acronym
- PROCTFUL
- Status last verified
- Sep 2008
- First submitted
- 6 Dec 2005
- Last updated
- 18 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
- ClinicalTrials.gov ID
- NCT00263029
- Acronym / sponsor ID
- PROCTFUL / L_8479
- Conditions
- Rectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Mar 2007 (actual)
- First posted
- 7 Dec 2005 (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 phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ECOG performance status score 0-1.
- Chemo-naïve patients.
- Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
- Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
- Adequate haematological, renal and liver functions as follows:
Key exclusion criteria (7 listed)
- Prior chemotherapy.
- Documented allergy to oxaliplatin or capecitabine.
- Prior radiotherapy to pelvis.
- Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
- Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
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 |
|---|---|---|
| Oxaliplatin60mg/m² as a 2-hour intravenous infusion every week for 5-6 week | Drug | 1 |
| Capecitabine500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart | Drug | 1 |
| RadiotherapyPlanned total dose of 45-50.4Gy (with cone down) in 25-28 fractions | Radiation | 1 |
Primary outcome
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
Time frame: 3-years disease- free-survival or 3-years overall survival
1 secondary outcome
Adverse events collection
Time frame: From the signature of the informed consent up to the end of the study
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 18 Sep 2009.
Related trials for Rectal Neoplasms
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 recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Iris CHAN, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Capecitabine and Radiotherapy in people with Rectal Neoplasms, run by Sanofi.
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 10 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate). (time frame: 3-years disease- free-survival or 3-years overall survival). 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 18 Sep 2009.