Liver CancerPhase 1NCT02893982
High Dose Rate Brachyablation of Primary Liver Lesions
A Phase 1 study testing brachytherapy in people with Liver Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The objectives of this study are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) while evaluating treatment… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 16 Mar 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologic or radiographic proof of a primary liver malignancy suitable for radiation therapy.
- Lesion size ≥ 3cm in maximum dimension.
- Predicted survival of >6 months.
- KPS ≥ 60 (See Appendix B).
- Age ≥ 18 years old.
- 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, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
- Formal evaluation by the Liver Tumor Program at UTSW: All patients should be fairly and prudently informed of their treatment options. To this end, all patients must be evaluated by the Liver Tumor Program at conference before brachytherapy treatment for discussion and consideration of other options for treatment of liver cancer including surgical resection.
Who cannot join
- Patients with a history of prior irradiation or other treatment to the liver or abdomen who after treatment on this protocol would have a cumulative dose to the liver or other normal tissues greater than the protocol defined constraints.
- Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, stereotactic body radiation therapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 4.4.1, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 4.4.2 and 4.4.3 is allowed. At least 4 weeks must have passed since the last directed intervention to the protocol-treated lesion.
- Germ cell or hematologic malignancies.
- History of Crohn's Disease or Ulcerative Colitis.
- Active peptic ulcer disease for lesions within 5cm of the stomach.
- Underlying hepatic cirrhosis with Child-Pugh class B9 or C
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- A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process.
- Men and women of reproductive potential may not participate unless they agree to use an effective contraceptive method.
- Pregnant or lactating women.
- Patients with parahepatic extension of disease with direct non-liver visceral involvement.
- Abnormal laboratory chemistries
- Albumin < 2.5
- Alkaline Phosphatase > 5 X upper limits of normal (ULN)
- LT/AST > 5 X ULN
- Total bilirubin > 5
- Abnormal complete blood count refractory to treatment. Any of the following:
- Platelet count < 75,000/ml
- Hb level < 8 gm/dl
- ANC < 500/ml
- Abnormal coagulation profile: INR > 2 and/or PTT > 80
- Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
- Contraindications to general anesthesia
- Subjects receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Therapeutic Dose Escalation Study Using Percutaneous Image-Guided Navigation for High Dose Rate Brachyablation of Primary Liver Lesions
The objectives of this study are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver lesions.
Read the detailed description
Primary endpoints of this protocol are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and then to determine the maximum tolerated dose (MTD) of navigated percutaneous interstitial HDR brachytherapy for liver lesions. Secondary endpoints include assessment of toxicity and oncologic outcome (primarily local control at the treated site) and exploratory endpoints will be supported by advanced imaging studies at the time of the treatment procedure.
The 25 Gy starting dose was chosen as it has been shown to be effective at controlling tumor, albeit with limited followup. The promising outcomes noted at that dose are predicated on actually delivering that dose, hence the feasibility endpoint for meeting the goal dose delivery. While the other primary endpoint will be toxicity so as to avoid exceeding the MTD, this trial will treat more patients at each level to better characterize both toxicity and efficacy within a dose level (the therapeutic window). The investigators will attempt to escalate to levels that modeling would predict to have durable local control approaching 100%.55 Dose escalation levels of 5 Gy were chosen to mirror other studies performed at this institution with SBRT
- Conditions
- Liver Cancer
- Being tested
- brachytherapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions
| Study group | Role | What they receive |
|---|---|---|
| brachytherapy | Experimental | image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions Receives: Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosimetric coverage of liver lesions
Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques, to provide dosimetric coverage of liver lesions such that:
- Minimum CTV peripheral dose ≥ 25 Gy (D100 ≥ 25 Gy)
- 67% or 700 cc Liver < 5 Gy
- Esophagus, stomach, bowel, or duodenum < 15 Gy to 1cc, < 12 Gy to 5cc, < 9 Gy to 10cc, and 85 Gy in BED(2Gy) equivalent including current and prior treatment to 1cc
- Spinal cord/cauda equina < 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment
- Kidney < 11 Gy, 200 cc < 8.4 Gy
- Spinal cord/cauda equina < 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment 5. Kidney < 11 Gy, 200 cc < 8.4 Gy Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques
Measured: 1 day
maximum tolerated dose
Determine the maximum tolerated dose (MTD) for percutaneous image-guided navigated high dose rate brachytherapy for liver lesions.
- Initial dose level; as above, minimum CTV peripheral dose ≥ 25 Gy
- Dose level 2: minimum CTV peripheral dose ≥ 30 Gy
- Dose level 3: minimum CTV peripheral dose ≥ 35 Gy
Measured: 90 days
Secondary outcomes (2)
severe toxicity
Demonstrate safety of HDR brachytherapy for lesions of the liver, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 Clavien-Dindo scale surgical complication score within 30 days of treatment or by NCI CTCAE v 4.0 toxicity after 30 days that is at least possibly related to treatment
Measured: 30 days
local control
Assess patients for duration of local control at the treatment site, as well as other oncologic outcomes including progression-free and overall survival.
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 posted9 Sep 2016 (estimated)
- Study start9 Nov 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Study was closed due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Folkert, University of Texas Southwestern Medical Center
- Investigators
- Michael Folkert, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893982
- Sponsor's protocol ID
- STU 102014-018
- Other IDs
- NCI-2017-02248
- Status last verified
- May 2021
- First submitted
- 2 Sep 2016
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Therapeutic Dose Escalation Study Using Percutaneous Image-Guided Navigation for High Dose Rate Brachyablation of Primary Liver Lesions
- ClinicalTrials.gov ID
- NCT02893982
- Acronym / sponsor ID
- STU 102014-018
- Conditions
- Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed due to poor accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 9 Sep 2016 (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 objectives of this study are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver lesions.
Detailed description
Primary endpoints of this protocol are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and then to determine the maximum tolerated dose (MTD) of navigated percutaneous interstitial HDR brachytherapy for liver lesions. Secondary endpoints include assessment of toxicity and oncologic outcome (primarily local control at the treated site) and exploratory endpoints will be supported by advanced imaging studies at the time of the treatment procedure.
The 25 Gy starting dose was chosen as it has been shown to be effective at controlling tumor, albeit with limited followup. The promising outcomes noted at that dose are predicated on actually delivering that dose, hence the feasibility endpoint for meeting the goal dose delivery. While the other primary endpoint will be toxicity so as to avoid exceeding the MTD, this trial will treat more patients at each level to better characterize both toxicity and efficacy within a dose level (the therapeutic window). The investigators will attempt to escalate to levels that modeling would predict to have durable local control approaching 100%.55 Dose escalation levels of 5 Gy were chosen to mirror other studies performed at this institution with SBRT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brachytherapy | Experimental | Radiation: brachytherapyimage-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologic or radiographic proof of a primary liver malignancy suitable for radiation therapy.
- Lesion size ≥ 3cm in maximum dimension.
- Predicted survival of >6 months.
- KPS ≥ 60 (See Appendix B).
- Age ≥ 18 years old.
Key exclusion criteria (23 listed)
- Patients with a history of prior irradiation or other treatment to the liver or abdomen who after treatment on this protocol would have a cumulative dose to the liver or other normal tissues greater than the protocol defined constraints.
- Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, stereotactic body radiation therapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 4.4.1, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 4.4.2 and 4.4.3 is allowed. At least 4 weeks must have passed since the last directed intervention to the protocol-treated lesion.
- Germ cell or hematologic malignancies.
- History of Crohn's Disease or Ulcerative Colitis.
- Active peptic ulcer disease for lesions within 5cm of the stomach.
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 |
|---|---|---|
| brachytherapyimage-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions | Radiation | brachytherapy |
Primary outcome
dosimetric coverage of liver lesions
Time frame: 1 day
Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques, to provide dosimetric coverage of liver lesions such that: 1. Minimum CTV peripheral dose ≥ 25 Gy (D100 ≥ 25 Gy) 2. 67% or 700 cc Liver < 5 Gy 3. Esophagus, stomach, bowel, or duodenum < 15 Gy to 1cc, < 12 Gy to 5cc, < 9 Gy to 10cc, and 85 Gy in BED(2Gy) equivalent including current and prior treatment to 1cc 4. Spinal cord/cauda equina < 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment 5. Kidney < 11 Gy, 200 cc < 8.4 Gy 4. Spinal cord/cauda equina < 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment 5. Kidney < 11 Gy, 200 cc < 8.4 Gy Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques
maximum tolerated dose
Time frame: 90 days
Determine the maximum tolerated dose (MTD) for percutaneous image-guided navigated high dose rate brachytherapy for liver lesions. 1. Initial dose level; as above, minimum CTV peripheral dose ≥ 25 Gy 2. Dose level 2: minimum CTV peripheral dose ≥ 30 Gy 3. Dose level 3: minimum CTV peripheral dose ≥ 35 Gy
2 secondary outcomes
severe toxicity
Time frame: 30 days
local control
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study was closed due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- 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.
Michael Folkert, MD principal investigator
University of Texas Southwestern Medical Center
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 brachytherapy in people with Liver Cancer, run by University of Texas Southwestern Medical Center 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 11 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: stopped early, as of the sponsor's last update on 18 May 2021. 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 was stopped early (reason given: Study was closed due to poor accrual). Results are not available in the source record.
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?
dosimetric coverage of liver lesions (time frame: 1 day). 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 18 May 2021.