Esophageal CancerPhase 2J10130NCT01372202
CHFR Methylation Status Esophageal Cancer Study
A Phase 2 study testing Paclitaxel, Cisplatin and Oxaliplatin in people with Esophageal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Paclitaxel, Cisplatin and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 1 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the esophagus or GE junction
- Patient must be untreated with chemotherapy, radiation therapy, or surgery for this diagnosis of esophageal cancer. (Endoscopy with biopsy and dilation is permitted.)
- Tumor must be located between 20 cm from the teeth endoscopically and 2 cm into the gastric cardia. Cervical esophageal cancers and true gastric cancers are excluded.
- Stage T2-3/N0-3/M0 as determined by imaging studies and biopsy where appropriate. T4 disease is permitted if defined as resectable by the thoracic surgeon (involvement of the pleura, pericardium or diaphragm).
- Patients must have had an endoscopic ultrasound
- Patients must have had a staging PET scan
Show all 18Show fewer
- Age ≥ 18 and ≤ 75
- ECOG performance status 0-1.
- Surgically resectable tumor
- Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds three years.
- Patients must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ 2 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
- creatinine < 1.5 X institutional ULN
- Female patients must not be pregnant or breast feeding. Radiotherapy is associated with significant birth defects and/or non-viable fetus. Paclitaxel, cisplatin, oxaliplatin, and 5-fluorouracil have teratogenic potential. A negative pregnancy test is required within 14 days of treatment for all women of childbearing potential. 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 she or her partner is participating in this study, the patient should inform the treating physician immediately.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients may not be receiving any investigational agents.
- Incomplete healing from previous major surgery.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents they are assigned to.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels paclitaxel. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.
- Uncontrolled, inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Patients from whom biopsy tissue cannot be obtained for correlate study analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies
This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.
Read the detailed description
Primary Objectives
- To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.
Secondary Objectives
- To determine the survival outcome with this treatment strategy.
- To determine time to disease progression with this treatment strategy.
- To determine the agreement between tumor CHFR methylation and detection in plasma.
- Conditions
- Esophageal Cancer
- Being tested
- Paclitaxel, Cisplatin, Oxaliplatin, 5-Fluorouracil, Radiotherapy
- Keywords
- Operable, Based on CHFR Methylation Status, Diagnostic Biopsies
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Abraxane, Taxol
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
CisplatinDrug
Also called Platinol
Paclitaxel and cisplatin:
- Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
- Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
- 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
- Cisplatin 75 mg/m² days 1, 29.
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-FluorouracilDrug
Also called 5-FU, Adrucil, Carac, Efudex
Oxaliplatin and 5-fluorouracil:
- Oxaliplatin 85 mg/m2 days 1, 15, 29.
- 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)
Cisplatin and 5-fluorouracil:
- 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
- Cisplatin 75 mg/m² days 1, 29.
RadiotherapyRadiation
Also called IMRT
Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
EsophagectomyProcedure or surgery
Also called Resection
The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy; Procedure: Esophagectomy |
| Arm B | Active comparator | Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Receives: Drug: Cisplatin; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Radiation: Radiotherapy; Procedure: Esophagectomy |
| Arm C | Active comparator | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Receives: Drug: Cisplatin; Drug: 5-Fluorouracil; Radiation: Radiotherapy; Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.
Measured: 3 years
Secondary outcomes (3)
Survival
Overall survival with given treatment strategy.
Measured: 3 years
Time to Disease Progression
To determine time to disease progression with this treatment strategy.
Measured: 3 years
Esophageal Tumor CHFR Methylation and Detection in Plasma
To determine the agreement between tumor CHFR methylation and detection in plasma.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2014
- Study completion1 Oct 2014
Why it stopped: Study stopped due to early stopping rule
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronan Kelly, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372202
- Sponsor's protocol ID
- J10130
- Other IDs
- NA_00042668, R33CA127055
- Acronym
- J10130
- Status last verified
- Jan 2019
- First submitted
- 9 Jun 2011
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies
- ClinicalTrials.gov ID
- NCT01372202
- Acronym / sponsor ID
- J10130 / J10130
- Conditions
- Esophageal Cancer
- Keywords
- Operable, Based on CHFR Methylation Status, Diagnostic Biopsies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to early stopping rule
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 30 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.
Detailed description
Primary Objectives
- To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.
Secondary Objectives
- To determine the survival outcome with this treatment strategy.
- To determine time to disease progression with this treatment strategy.
- To determine the agreement between tumor CHFR methylation and detection in plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Paclitaxel, Drug: Cisplatin, Radiation: Radiotherapy, Procedure: EsophagectomyPaclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy |
| Arm B | Active comparator | Drug: Cisplatin, Drug: Oxaliplatin, Drug: 5-Fluorouracil, Radiation: Radiotherapy, Procedure: EsophagectomyCisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
| Arm C | Active comparator | Drug: Cisplatin, Drug: 5-Fluorouracil, Radiation: Radiotherapy, Procedure: EsophagectomyCisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed adenocarcinoma of the esophagus or GE junction
- Patient must be untreated with chemotherapy, radiation therapy, or surgery for this diagnosis of esophageal cancer. (Endoscopy with biopsy and dilation is permitted.)
- Tumor must be located between 20 cm from the teeth endoscopically and 2 cm into the gastric cardia. Cervical esophageal cancers and true gastric cancers are excluded.
- Stage T2-3/N0-3/M0 as determined by imaging studies and biopsy where appropriate. T4 disease is permitted if defined as resectable by the thoracic surgeon (involvement of the pleura, pericardium or diaphragm).
- Patients must have had an endoscopic ultrasound
Key exclusion criteria (7 listed)
- Patients may not be receiving any investigational agents.
- Incomplete healing from previous major surgery.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents they are assigned to.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels paclitaxel. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.
- Uncontrolled, inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| PaclitaxelAlso: Abraxane, TaxolPaclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. | Drug | Arm A |
| CisplatinAlso: PlatinolPaclitaxel and cisplatin: * Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. * Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32. * Cisplatin 75 mg/m² days 1, 29. | Drug | Arm A, Arm B, Arm C |
| OxaliplatinAlso: EloxatinOxaliplatin 85 mg/m2 days 1, 15, 29. | Drug | Arm B |
| 5-FluorouracilAlso: 5-FU, Adrucil, Carac, EfudexOxaliplatin and 5-fluorouracil: * Oxaliplatin 85 mg/m2 days 1, 15, 29. * 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days) Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32. * Cisplatin 75 mg/m² days 1, 29. | Drug | Arm B, Arm C |
| RadiotherapyAlso: IMRTPatients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. | Radiation | Arm A, Arm B, Arm C |
| EsophagectomyAlso: ResectionThe type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). | Procedure or surgery | Arm A, Arm B, Arm C |
Primary outcome
Pathological Complete Response
Time frame: 3 years
CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.
3 secondary outcomes
Survival
Time frame: 3 years
Time to Disease Progression
Time frame: 3 years
Esophageal Tumor CHFR Methylation and Detection in Plasma
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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.
Ronan Kelly, M.D. principal investigator
Johns Hopkins University
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 Paclitaxel, Cisplatin and Oxaliplatin in people with Esophageal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 18 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: stopped early, as of the sponsor's last update on 25 Jan 2019. 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 30 Aug 2017). 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?
Pathological Complete Response (time frame: 3 years). 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 25 Jan 2019.