Rectal CancerPhase 1NCT02178644
Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer
A Phase 1 study testing Chemo with concomitant Capecitabine and KD018 in people with Rectal Cancer, run by Yale University at 1 site in United States.
Trial summary
This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer. 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?
- Chemo with concomitant Capecitabine and KD018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 20 Sep 2019
- 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
- Patients must have histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the rectum with the inferior margin within 16 cm from the anal verge.
- Patients must have had a Transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS) staging within two months prior to treatment start.
- Patients must have had a pelvic MRI within 28 days prior to the initiation of treatment.
- Patient must have the ability to swallow multiple capsules.
- Women of child bearing potential between the ages of 18 and 60 years of age must have a negative urine pregnancy test prior to undergoing simulation in preparation for radiation therapy to the pelvis.
- ECOG performance status of 0 to 1 within 28 days prior to initiation of treatment.
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- Patients must have normal organ and marrow function as defined below. All laboratory values must be obtained within 14 days prior to initiation of treatment:
- absolute neutrophil count >= 1,500/mcL
- platelets >= 100,000/mcL
- hemoglobin >= 8.0 g/ dL
- serum bilirubin < 1.5 times the upper limit of of normal (ULN)
- serum AST, ALT < 2.5 times ULN
- serum Creatinine ≤ 1.5 times ULN
- The effects of radiation on the developing human fetus are known to be teratogenic. For this reason, all women and sexually active 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.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of clinically significant Crohn's disease or inflammatory bowel disease (IBD).
- Active collagen vascular disease.
- History of previous abdominal or pelvic radiation therapy.
- History of previous systemic chemotherapy unless given curatively for other malignancy now > 5 years without evidence of recurrence.
- Patients with suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the investigator to be likely to affect their ability to sign the informed consent, or undergo study procedures will be excluded.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with either KD018 or Capecitabine, breastfeeding should be discontinued if the mother is treated.
- Patients with known HIV infection or viral hepatitis.
- Patients with Dihydropyrimidine dehydrogenase (DPD) deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.
Read the detailed description
This pilot study focuses on KD018, a standardized and well-characterized Chinese herbal medicine, and will investigate the effect of this agent on reducing the GI toxicity associated with combined modality therapy of locally-advanced rectal cancer. In this study, KD018 will be administered concomitantly with Capecitabine and pelvic radiation therapy (RT) in the neoadjuvant setting, with the hypothesis that KD018 will reduce the gastrointestinal side effects, namely diarrhea, secondary to treatment with Capecitabine plus external beam radiation therapy (EBRT).
The primary endpoint of the study is to investigate the grade 3-4 toxicity rate associated with a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. Secondary objectives include the assessment of radiographic response to therapy (using pelvic MRI) and assessment of the pathologic CR rate by examination of the pathologic specimen. In addition, we will perform an analysis of plasma levels of pro-inflammatory cytokines and chemokines.
This trial is designed to accrue approximately 24 patients over the course of 24 months.
- Conditions
- Rectal Cancer
- Being tested
- Chemo with concomitant Capecitabine and KD018
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo with concomitant Capecitabine and KD018Drug
Also called KD018, Capecitabine, Neo-Adjuvant Concurrent Chemo-Radiation Therapy
Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Chemo with concomitant Capecitabine and KD018 | Experimental | Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. Receives: Drug: Chemo with concomitant Capecitabine and KD018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3-4 Toxicity Rate
Grade 3-4 toxicity rate will be described as greatest toxicity per patient/total patients evaluable for toxicity +/- 95% confidence interval.
Measured: Up to 10 Months
pCR Rate
pCR (CR = Complete Response) rate will be defined as number of patients with pathologic complete response divided by number of patients treated (pCR IIT) and divided by those undergoing surgical resection (pCR actual) +/- 95% confidence interval.
Measured: Up to 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
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 Yale 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan A Higgins, M.D., M.S., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178644
- Sponsor's protocol ID
- 1404013708
- Status last verified
- Oct 2020
- First submitted
- 26 Jun 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02178644
- Acronym / sponsor ID
- 1404013708
- Conditions
- Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 1 Jul 2014 (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 pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.
Detailed description
This pilot study focuses on KD018, a standardized and well-characterized Chinese herbal medicine, and will investigate the effect of this agent on reducing the GI toxicity associated with combined modality therapy of locally-advanced rectal cancer. In this study, KD018 will be administered concomitantly with Capecitabine and pelvic radiation therapy (RT) in the neoadjuvant setting, with the hypothesis that KD018 will reduce the gastrointestinal side effects, namely diarrhea, secondary to treatment with Capecitabine plus external beam radiation therapy (EBRT).
The primary endpoint of the study is to investigate the grade 3-4 toxicity rate associated with a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. Secondary objectives include the assessment of radiographic response to therapy (using pelvic MRI) and assessment of the pathologic CR rate by examination of the pathologic specimen. In addition, we will perform an analysis of plasma levels of pro-inflammatory cytokines and chemokines.
This trial is designed to accrue approximately 24 patients over the course of 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo with concomitant Capecitabine and KD018 | Experimental | Drug: Chemo with concomitant Capecitabine and KD018Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the rectum with the inferior margin within 16 cm from the anal verge.
- Patients must have had a Transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS) staging within two months prior to treatment start.
- Patients must have had a pelvic MRI within 28 days prior to the initiation of treatment.
- Patient must have the ability to swallow multiple capsules.
- Women of child bearing potential between the ages of 18 and 60 years of age must have a negative urine pregnancy test prior to undergoing simulation in preparation for radiation therapy to the pelvis.
Key exclusion criteria (8 listed)
- History of clinically significant Crohn's disease or inflammatory bowel disease (IBD).
- Active collagen vascular disease.
- History of previous abdominal or pelvic radiation therapy.
- History of previous systemic chemotherapy unless given curatively for other malignancy now > 5 years without evidence of recurrence.
- Patients with suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the investigator to be likely to affect their ability to sign the informed consent, or undergo study procedures will be excluded.
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 |
|---|---|---|
| Chemo with concomitant Capecitabine and KD018Also: KD018, Capecitabine, Neo-Adjuvant Concurrent Chemo-Radiation TherapyPatients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. | Drug | Chemo with concomitant Capecitabine and KD018 |
Primary outcome
Grade 3-4 Toxicity Rate
Time frame: Up to 10 Months
Grade 3-4 toxicity rate will be described as greatest toxicity per patient/total patients evaluable for toxicity +/- 95% confidence interval.
pCR Rate
Time frame: Up to 10 Months
pCR (CR = Complete Response) rate will be defined as number of patients with pathologic complete response divided by number of patients treated (pCR IIT) and divided by those undergoing surgical resection (pCR actual) +/- 95% confidence interval.
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 8 Oct 2020.
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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.
Susan A Higgins, M.D., M.S. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chemo with concomitant Capecitabine and KD018 in people with Rectal Cancer, run by Yale University 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 8 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 Oct 2020. 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 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?
Grade 3-4 Toxicity Rate (time frame: Up to 10 Months). 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 Oct 2020.