High Dose Rate Brachyablation of Primary Liver Lesions

NCT02893982 | Terminated Phase 1 DMC FDA Device

• 2 other identifiers: STU 102014-018NCI-2017-02248
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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 delivery, safety, and efficacy utilizing a pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver lesions.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (2)

• 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: 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

  1 day

• maximum tolerated dose

  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

  90 days

Secondary Outcomes (2)

• severe toxicity

  30 days

• local control

  2 years

Study Arms (1)

brachytherapy

EXPERIMENTAL

image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions

Radiation: brachytherapy

Interventions

brachytherapy RADIATION

image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions

brachytherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Michael Folkert, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 9, 2016
• Study Start: November 9, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)