Esophageal NeoplasmNCT01035437
Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer
A study testing HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a) in people with Esophageal Neoplasm, run by Roswell Park Cancer Institute.
Trial summary
This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy following photodynamic therapy have on esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Feb 2011
- Phase
- Interventional
- 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
- Partially or completely obstructing primary esophageal carcinoma, clinical stage I-IVa as determined by endoscopy, CT-scan, PET +/- endoscopic ultrasound. For distal esophagus tumors involving the GE junction, at least 50% or greater of the tumor bulk should be in the distal esophagus
- Ineligible for or refused surgical resection
- No Prior therapy allowed for esophageal cancer
- ECOG Performance status 0-1
- Life expectancy > 4 months
- Adequate hematologic parameters (hemoglobin> 9g/dl, ANC > 1500/ul, Platelets > 100,000/ul)
Show all 13Show fewer
- Adequate biochemical parameters (total bilirubin and creatinine within institutional limits, AST and alkaline phosphatase less tham or equal to 3xUNL)
- Age > 18 years
- Signed informed consent
- Bronchoscopy with biopsy and cytology if primary esophageal cancer is < 26 cm from incisors
- Female patients of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to registration
- Patients of Childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method
- Both men and women and members of all races and ethnic are eligible for this trial
Who cannot join
- Hypersensitivity to platinum compounds, fluoropyrimidines or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases should be excluded from this trail
- Uncontrolled intercurrent 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
- Peripheral neuropathy ≥ Grade 2
- History of second malignancy within the previous years except for curatively treated carcinoma of the cervix in-situ or non-melanomatous skin cancer
Show all 12Show fewer
- Patients who are pregnant or lactating
- Porphyria or hypersensitivity to porphyrin-like compounds
- Patients with known HIV or Hepatitis B or C (active, previously treated or both)
- Patients with tracheal or bronchial involvement, as determined by bronchoscopy
- Patients with documented unilateral or bilateral vocal cord paralysis
- Patients with T4 lesions by CT, MRI or EUS involving the aorta, lung or pericardium
About this study
Official title: A Pilot Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer
This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy following photodynamic therapy have on esophageal cancer.
- Conditions
- Esophageal Neoplasm
- Being tested
- HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
- Keywords
- obstructing
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)Drug
HPPH in D5W, 4.0 mg/m2 infused over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| HPPH | Experimental | HPPH Receives: Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer
Measured: 2 year
Secondary outcomes (1)
Evaluate the efficacy of PDT in palliation of dysphagia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionFeb 2011
Why it stopped: no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikhil Khushalani, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035437
- Sponsor's protocol ID
- RPCI I 148809
- Status last verified
- Jun 2012
- First submitted
- 17 Dec 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01035437
- Acronym / sponsor ID
- RPCI I 148809
- Conditions
- Esophageal Neoplasm
- Keywords
- obstructing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Dec 2009 (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 study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy following photodynamic therapy have on esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPPH | Experimental | Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)HPPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Partially or completely obstructing primary esophageal carcinoma, clinical stage I-IVa as determined by endoscopy, CT-scan, PET +/- endoscopic ultrasound. For distal esophagus tumors involving the GE junction, at least 50% or greater of the tumor bulk should be in the distal esophagus
- Ineligible for or refused surgical resection
- No Prior therapy allowed for esophageal cancer
- ECOG Performance status 0-1
- Life expectancy > 4 months
Key exclusion criteria (12 listed)
- Hypersensitivity to platinum compounds, fluoropyrimidines or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases should be excluded from this trail
- Uncontrolled intercurrent 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
- Peripheral neuropathy ≥ Grade 2
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 |
|---|---|---|
| HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)HPPH in D5W, 4.0 mg/m2 infused over 1 hour | Drug | HPPH |
Primary outcome
Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer
Time frame: 2 year
1 secondary outcome
Evaluate the efficacy of PDT in palliation of dysphagia
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
Related trials for Esophageal Neoplasm
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder 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.
Nikhil Khushalani, MD principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a) in people with Esophageal Neoplasm, run by Roswell Park Cancer Institute.
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 13 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 Jul 2012. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer (time frame: 2 year). 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 2 Jul 2012.