“Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in hepatocelluar carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Progression at 1 year: local, intra- and extrahepatic progression
研究概览
简要总结
HCC a major health problem worldwide, more so in developing countries especially in Asia and Africa and has a dismal prognosis particularly in advance stages. SBRT an emerging radiation treatment modality offers a potential therapy for sustained local control or potentially valuable salvage therapy for many tumour types including all stages of HCC. For unresectable cases of HCC, both TACE and SBRT have been used but there has not been any randomized trial to compare between these two modalities. Therefore, a clinical study comparing SBRT and TACE will be very significant as it addresses a common problem especially in Asia and Africa. So If positive then the results will redefine standards of care for HCC. As of now we cannot describe any direct benefits to patient or society.
Objectives of the project: To demonstrate non-inferiority of SBRT compared to TACE in terms of any disease progression in patients with HCC, who have not previously received SBRT or TACE.
Expected outcomes:This is a non-inferiority study with the objective to demonstrate non-inferiority of SBRT to TACE in terms of any disease progression in patients with HCC, who have not previously received SBRT or TACE. On the basis of phase II data the present study tests if use of SBRT is associated with improved progression free survival in patients with hepatocellular cancer. If positive then the results will provide another alternative standard of care for HCCSBRT if redefined as an alternative standard can be completed in 2weeks whereas 3-4 TACE procedures take upto 4-5 months of treatment and are associated with significant procedureal costs. Additionally multiple visits and investigations prior to procedure add on to the treatment delivery costs. If SBRT is found to be non inferior it will also provide a more cost effective alternative for treatment of patients with unresectable HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢HCC (biopsy or radiological diagnostic (>1 cm, enhancing in arterial phase and wash-out in later phases).
- •â€¢Number of lesions: not more than 3 lesions •Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion) •Child-Pugh A or B (<7) on examination within 6 weeks prior to study entry •BCLC Stage A/B •Must be fit (eligible) for SBRT and TACE •Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available •Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is >10 mm •All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows: oAbsolute neutrophil count (ANC) ≥ 1,500 cells/mm3 oPlatelets ≥50,000 cells/mm3 oHemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) oTotal bilirubin < 2 mg/dL oProthrombin time/INR < 1.4 (unless on Coumadin/Warfarin) oAlbumin ≥ 28 g/L oAST (and ALT) < 5 times ULN oSerum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min oMay have had previous surgery, ethanol injection and RFA to the liver.
排除标准
- •â€¢Not suitable for clinical trial or follow-up •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible) .
- •No active cancer therapy.
- •â€¢Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) Raoul et al (2011) oNon-enhancing HCC on CT or CT-angio or oPortal vein thrombosis/macroscopic venous invasion •Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug).
- •â€¢Evidence of metastatic disease including nodal or distant metastases.
- •â€¢Previous TACE or radiation to the liver (including SIRT) •Life-threatening condition (including untreated HIV and active hepatitis B/C) oDetectable HBeAg and HBV viral load > 20,000 IU/mL or oHBeAg-negative chronic hepatitis B and HBV viral load >2,000 IU/mL oIf HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks.
- •oIf anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease.
- •Active HCV should be treated sufficiently before inclusion in the study.
- •Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy.
- •oPatients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial •On sorafenib or other antineplastic drug therapy within 7 days before inclusion (not accepted until time of progression).
- •â€¢Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days.
结局指标
主要结局
Progression at 1 year: local, intra- and extrahepatic progression
时间窗: 1 year
次要结局
- •Response rate(•Local failure –)