Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC

NCT02473536 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: STU 022015-058
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and feasibility of pre-operative SABR of RCC IVC tumor thrombus. To evaluate the effect of pre-operative SABR in RCC IVC tumor thrombus on relapse free survival at one year.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• To determine the feasibility of neoadjuvant SABR followed immediately by IVC tumor thrombectomy

  The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.

  90 days

• To determine the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy

  The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.

  90 days

• Survival at one year

  Phase II To determine the relapse-free survival at one-year

  ONE YEAR

Secondary Outcomes (9)

• Peri-operative morbidity

  90 days

• Adverse events post surgery

  1 year

• Recurrence free survival (1 year)

  1 year

• Recurrence free survival overall

  7 years

• Recurrence

  7 years

Study Arms (1)

Stereotactic ablative radiation therapy

EXPERIMENTAL

SABR

Radiation: Stereotactic ablative radiation therapy

Interventions

Stereotactic ablative radiation therapy RADIATION

SABR

Stereotactic ablative radiation therapy

Eligibility Criteria

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

You may qualify if:

• Radiographic evidence of renal cancer with IVC tumor thrombus
• Tumor thrombus must be ≥ level II (As per Mayo classification, it would be ≥ level I \[Refer to NEVES, R. and ZINCKE, H. (1987), Surgical Treatment of Renal Cancer with Vena Cava Extension. British Journal of Urology, 59: 390-395. doi:10.1111/j.1464-410X.1987.tb04832.x\])
• Patient eligible for SABR to the IVC tumor thrombus as decided by the treating radiation oncologist
• Patient eligible for IVC tumor thrombectomy as decided by the treating urologist
• Any number of metastatic disease is allowed in the Pilot phase of the trial
• For Phase II, metastatic patients will be allowed only if all sites of metastasis has been treated either surgically or radio-surgically (If limited sites of metastasis are present, all of which can be resected during the nephrectomy, then the patient can be eligible)
• Age ≥ 18 years.
• Performance status ECOG 0-2
• Any serum Albumin is allowed, but ≥ 3.4 g/dL is strongly encouraged
• Serum albumin \<3.4 is a significant predictor of peri-operative mortality(12)
• Any serum AST is allowed but serum AST ≤ 34 IU/L is strongly encouraged
• Significant predictor of mortality in univariate but not multivariate analysis(12)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal such as birth control pills, patch or ring; Depo-Provera, Implanon or barrier method, such as condom or diaphragm used with a spermicide of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of radiation 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 childbearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or

You may not qualify if:

• Subjects who have had radiotherapy to a target within 3 cm of the IVC tumor thrombus.
• Subjects may have received any other investigational agents or chemotherapy as long as they are eligible for SABR and surgery
• Subjects with brain metastases should be excluded from this clinical trial unless all the metastasis are treated surgically or radio-surgically
• Subjects with a history of pulmonary embolism is excluded
• Subjects with a history of pulmonary hypertension is excluded
• Subjects must not be pregnant due to the potential for congenital abnormalities.
• Contraindication for contrast-enhanced MRI as defined by the standard operating procedures of the Department of Radiology at UT Southwestern. Briefly, these include medically unstable; cardiac pacemaker; intracranial clips, metal implants; metal in the eyes; pregnant or nursing; claustrophobia; and impairment of the renal function with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2. Patients with one or more of these contraindications but eligible to undergo contrast-enhanced CT can participate in this study and will not receive an MRI

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Raquibul Hannan, MD

  UTSW

  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

Model Details: 6 for Lead-in phase; 23 for phase II

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)