Recurrent Rectal CancerPhase 1NCT01740648
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
A Phase 1 study testing trametinib, fluorouracil and radiation therapy in people with Recurrent Rectal Cancer and Stage IIA Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
Trial summary
This phase I trial studies the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery in treating patients with stage II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Rectal Cancer, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer
- What is being tested?
- trametinib, fluorouracil and radiation therapy
- 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
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Nov 2012to 29 Sep 2021
- Phase
- Phase 1
- 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
Who may be able to join
- All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
- Absolute neutrophil count >= 1.5 x 10^9/L
- Hemoglobin >= 9 g/dL
- Platelets >= 100 x 10^9/L
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)
- Partial thromboplastin time (PTT) =< 1.5 x ULN
Show all 22Show fewer
- Albumin >= 2.5 g/dL
- Total bilirubin =< 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
- Creatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min
- Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
- Life expectancy of at least 3 months in the opinion of investigator
- Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment, and counseled on contraception/abstinence while receiving the study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
- A histologically confirmed rectal cancer with measurable or evaluable disease on imaging or endoscopy
- Stage II or III disease by the American Joint Committee on Cancer (AJCC) 7th edition
- Specific tumor genetic eligibility criteria include:
- Presence of KRAS gene mutation (at codon 12, 13, or 61) for patients on expansion cohort.
- Presence of V600E BRAF gene mutation, or
- Presence of an NRAS mutation at codon 12, 13, or 61
Who cannot join
- History of another malignancy; exception: subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
- Prior chemotherapy treatment unless > 5 years ago
- Prior treatment with a selective inhibitor of v-raf-1 murine leukemia viral oncogene homolog 1 (RAF) or mitogen-activated protein kinase kinase 1 (MEK)
- Prior radiation therapy to the abdomen or pelvis
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO)
Show all 23Show fewer
- Current use of a prohibited medication
- History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
- History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
- Evidence of optic disc cupping
- Evidence of visual field defects
- Intraocular pressure > 21 mm Hg
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed)
- History or evidence of cardiovascular risk including any of the following:
- Bazett correction QT (QTcB) >= 480 msec
- History or evidence of current clinically significant uncontrolled arrhythmias; exception: subjects with controlled atrial fibrillation for >30 days prior to enrollment are eligible
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
- History or evidence of current >= class II congestive heart failure as defined by New York Heart Association (NYHA)
- Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
- Patients with intra-cardiac defibrillators or permanent pacemakers
- Cardiac metastases
- Pregnancy or breastfeeding: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; no breastfeeding while patient is on study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Vanderbilt University
Nashville, Tennessee, 37235
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase I Trial of MEK Inhibitor Trametinib in Combination With Neoadjuvant 5-Fluorouracil Chemoradiation in the Treatment of KRAS, BRAF, and NRAS-MUTANT Rectal Cancers
This phase I trial studies the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery in treating patients with stage II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving trametinib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
Read the detailed description
PRIMARY OBJECTIVES:
- To identify the maximally tolerated dose and recommended phase II dose of trametinib to be used in combination with 5FU (fluorouracil) and radiation in patients with rectal cancers.
II. To determine a recommended phase II dose of trametinib to be used with 5FU chemoradiation in patients with locally advanced rectal cancer.
SECONDARY OBJECTIVES:
- Evaluation of the tolerability and safety of the combination of trametinib and 5-FU chemoradiation in locally advanced rectal cancer.
II. Evaluation of post-therapy pathologic response.
III. Evaluation of the rate of local control, disease-free survival and overall survival.
IV. Analysis of biomarkers - total mutations in v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), v-raf murine sarcoma viral oncogene homolog B1(BRAF), and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS), as well as RAS/mitogen-activated protein kinase (MAPK) and phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT) pathway signaling pathways to potentially correlate with clinical benefit.
OUTLINE: This is a dose-escalation study of trametinib.
Patients receive trametinib orally (PO) once daily (QD) on days -14 to -10 and 1-38 and fluorouracil intravenously (IV) continuously 5 days a week from days 1-38. Patients also undergo radiation therapy 5 days a week on days 1-33. Patients then undergo surgery 6-10 weeks later.
Patients achieving negative surgical margins after complete resection of tumor receive postoperative chemotherapy comprising leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 OR oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually for 3 years.
- Conditions
- Recurrent Rectal Cancer, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage IIIA Rectal Cancer, Stage IIIB Rectal Cancer
- Being tested
- trametinib, fluorouracil, radiation therapy
- Keywords
- MEK Inhibitor, Trametinib, Rectal Cancers, KRAS, BRAF, NRAS Mutant, Fluorouracil
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trametinibDrug
Also called GSK1120212
Trametinib will be given for 5-day lead-in period by mouth daily Monday-Friday starting at day -14 through -10 and concurrently for the duration of radiation therapy (approximately days 1-38).The dose of Trametinib will be escalated: 0.5 mg, 1.0 mg, 2mg. If the 2 mg dose level causes DLT (dose-limiting toxicity)in 2 out of 6 patients and the 1mg dose level was acceptable, then a 1.5 mg dose cohort will be used.
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Will be administered as a continuous infusion over 120 hours at a dose of 225 mg/m2/day on Monday to Friday of every week starting day 1-38.
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Radiation therapy will be delivered to the pelvis during (approximately) days 1-33 (five days a week, Mondays through Fridays for 25 fractions) using a 3-field or 4-field 3-D conformal plan to the primary tumor, surrounding soft tissues, and at risk lymph node stations (peri-rectal, presacral, internal iliac, with or without external iliac) to a total dose of 45 Gy in 1.8 Gy daily fractions. A boost radiation field will be delivered during (approximately) days 36-38. The boost will encompass the primary rectal tumor and involved lymph nodes with a 2-2.5 cm margin, which should include the presacral space. The boost dose will be 5.4 Gy in 1.8 Gy fractions for a total dose of 50.4 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (trametinib, fluorouracil, radiation, surgery) | Experimental | Patients receive trametinib PO (by mouth) QD (daily) on days -14 through -10 and 1-38 and fluorouracil IV continuously 5 days a week from days 1-38. Patients also undergo radiation therapy 5 days a week on days 1-33. Patients then undergo surgery 6-10 weeks later.
Patients achieving negative surgical margins after complete resection of tumor receive postoperative chemotherapy comprising leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 OR oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: trametinib; Drug: fluorouracil; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the maximally tolerated dose of Trametinib to be used in combination with 5FU and radiation in patients with rectal cancers.
Measured: up to 9 weeks
Secondary outcomes (6)
Frequency of dose-limiting toxicities, assessed according to the NCI CTCAE version 4
The observed adverse events and their grade and attribution for each dose level, and patterns reflecting tolerability of the regimen will be summarized through graphical analysis and descriptive summaries.
Measured: up to 9 weeks
Local failure rate
Will be described graphically and quantitatively using the methods of Kaplan and Meier.
Measured: From the time of study enrollment until the first documented date of local failure, assessed up to 5 years
Progression free survival
Will be described graphically and quantitatively using the methods of Kaplan and Meier.
Measured: From the time of study enrollment until the first documented date of disease progression, assessed up to 5 years
Overall survival
Will be described graphically and quantitatively using the methods of Kaplan and Meier.
Measured: From the time of study enrollment until the time of death, assessed up to 5 years
Pathological response rate, defined as extent of tumor in the resected specimen that is classified by tumor, lymph node, metastasis (TNM) staging of the AJCC/International Union Against Cancer (UICC)
Assuming that this measure is binomially distributed, the proportion will be estimated and corresponding 95% binomial confidence intervals generated.
Measured: Up to 5 years
Frequency of patients undergoing sphincter preserving surgery
Assuming that this measure is binomially distributed, the proportion will be estimated and corresponding 95% binomial confidence intervals generated.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start26 Nov 2012
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center
- Investigators
- Sameek Roychowdhury, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740648
- Sponsor's protocol ID
- OSU-12054
- Other IDs
- NCI-2012-02158
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2012
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of MEK Inhibitor Trametinib in Combination With Neoadjuvant 5-Fluorouracil Chemoradiation in the Treatment of KRAS, BRAF, and NRAS-MUTANT Rectal Cancers
- ClinicalTrials.gov ID
- NCT01740648
- Acronym / sponsor ID
- OSU-12054
- Conditions
- Recurrent Rectal Cancer, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage IIIA Rectal Cancer, Stage IIIB Rectal Cancer
- Keywords
- MEK Inhibitor, Trametinib, Rectal Cancers, KRAS, BRAF, NRAS Mutant, Fluorouracil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Novartis Pharmaceuticals
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 4 Dec 2012 (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 phase I trial studies the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery in treating patients with stage II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving trametinib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
Detailed description
PRIMARY OBJECTIVES:
- To identify the maximally tolerated dose and recommended phase II dose of trametinib to be used in combination with 5FU (fluorouracil) and radiation in patients with rectal cancers.
II. To determine a recommended phase II dose of trametinib to be used with 5FU chemoradiation in patients with locally advanced rectal cancer.
SECONDARY OBJECTIVES:
- Evaluation of the tolerability and safety of the combination of trametinib and 5-FU chemoradiation in locally advanced rectal cancer.
II. Evaluation of post-therapy pathologic response.
III. Evaluation of the rate of local control, disease-free survival and overall survival.
IV. Analysis of biomarkers - total mutations in v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), v-raf murine sarcoma viral oncogene homolog B1(BRAF), and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS), as well as RAS/mitogen-activated protein kinase (MAPK) and phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT) pathway signaling pathways to potentially correlate with clinical benefit.
OUTLINE: This is a dose-escalation study of trametinib.
Patients receive trametinib orally (PO) once daily (QD) on days -14 to -10 and 1-38 and fluorouracil intravenously (IV) continuously 5 days a week from days 1-38. Patients also undergo radiation therapy 5 days a week on days 1-33. Patients then undergo surgery 6-10 weeks later.
Patients achieving negative surgical margins after complete resection of tumor receive postoperative chemotherapy comprising leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 OR oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trametinib, fluorouracil, radiation, surgery) | Experimental | Drug: trametinib, Drug: fluorouracil, Radiation: radiation therapyPatients receive trametinib PO (by mouth) QD (daily) on days -14 through -10 and 1-38 and fluorouracil IV continuously 5 days a week from days 1-38. Patients also undergo radiation therapy 5 days a week on days 1-33. Patients then undergo surgery 6-10 weeks later. Patients achieving negative surgical margins after complete resection of tumor receive postoperative chemotherapy comprising leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 OR oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
- Absolute neutrophil count >= 1.5 x 10^9/L
- Hemoglobin >= 9 g/dL
- Platelets >= 100 x 10^9/L
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)
Key exclusion criteria (23 listed)
- History of another malignancy; exception: subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
- Prior chemotherapy treatment unless > 5 years ago
- Prior treatment with a selective inhibitor of v-raf-1 murine leukemia viral oncogene homolog 1 (RAF) or mitogen-activated protein kinase kinase 1 (MEK)
- Prior radiation therapy to the abdomen or pelvis
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 |
|---|---|---|
| trametinibAlso: GSK1120212Trametinib will be given for 5-day lead-in period by mouth daily Monday-Friday starting at day -14 through -10 and concurrently for the duration of radiation therapy (approximately days 1-38).The dose of Trametinib will be escalated: 0.5 mg, 1.0 mg, 2mg. If the 2 mg dose level causes DLT (dose-limiting toxicity)in 2 out of 6 patients and the 1mg dose level was acceptable, then a 1.5 mg dose cohort will be used. | Drug | Treatment (trametinib, fluorouracil, radiation, surgery) |
| fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUWill be administered as a continuous infusion over 120 hours at a dose of 225 mg/m2/day on Monday to Friday of every week starting day 1-38. | Drug | Treatment (trametinib, fluorouracil, radiation, surgery) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationRadiation therapy will be delivered to the pelvis during (approximately) days 1-33 (five days a week, Mondays through Fridays for 25 fractions) using a 3-field or 4-field 3-D conformal plan to the primary tumor, surrounding soft tissues, and at risk lymph node stations (peri-rectal, presacral, internal iliac, with or without external iliac) to a total dose of 45 Gy in 1.8 Gy daily fractions. A boost radiation field will be delivered during (approximately) days 36-38. The boost will encompass the primary rectal tumor and involved lymph nodes with a 2-2.5 cm margin, which should include the presacral space. The boost dose will be 5.4 Gy in 1.8 Gy fractions for a total dose of 50.4 Gy. | Radiation | Treatment (trametinib, fluorouracil, radiation, surgery) |
Primary outcome
Identify the maximally tolerated dose of Trametinib to be used in combination with 5FU and radiation in patients with rectal cancers.
Time frame: up to 9 weeks
6 secondary outcomes
Frequency of dose-limiting toxicities, assessed according to the NCI CTCAE version 4
Time frame: up to 9 weeks
Local failure rate
Time frame: From the time of study enrollment until the first documented date of local failure, assessed up to 5 years
Progression free survival
Time frame: From the time of study enrollment until the first documented date of disease progression, assessed up to 5 years
Overall survival
Time frame: From the time of study enrollment until the time of death, assessed up to 5 years
Pathological response rate, defined as extent of tumor in the resected specimen that is classified by tumor, lymph node, metastasis (TNM) staging of the AJCC/International Union Against Cancer (UICC)
Time frame: Up to 5 years
Frequency of patients undergoing sphincter preserving surgery
Time frame: Up to 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 18 Sep 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sameek Roychowdhury, MD principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trametinib, fluorouracil and radiation therapy in people with Recurrent Rectal Cancer and Stage IIA Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 4 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 22 inclusion and 23 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Identify the maximally tolerated dose of Trametinib to be used in combination with 5FU and radiation in patients with rectal cancers. (time frame: up to 9 weeks). 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 2023.