Stereotactic Body Radiation Therapy after Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: The STRONG Trial, a Phase I Safety and Feasibility Study

Baak, Rogier; Willemssen, F.; Norden, Yvette van; Eskens, Ferry A.L.M.; Milder, Maaike T. W.; Heijmen, B.; Koerkamp, Bas Groot; Sprengers, Dave; Driel, Lydi M.J.W. van; Klümpen, Heinz‐Josef; Toom, Wilhelm den; Koedijk, Merel S.; IJzermans, Jan N. M.; Romero, Alejandra Méndez

doi:10.3390/cancers13163991

Cited by 9 publications

(16 citation statements)

References 32 publications

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“…The gross tumor volume (GTV) was defined in average intensity projection CT images at exhalation (gated) phases (i.e., 30% of the entire respiration cycle in each patient) based on available imaging studies, including liver dynamic CT and/or MRI. The internal target volume (ITV) and organs at risk (OARs) were defined to account for the extent and movement of the GTV and each OAR at the exhalation (gated) phases, and the clinical target volume was defined as the ITV with no additional margins [ 25 , 27 , 31 , 32 , 34 , 36 ]. The planning target volume (PTV) was defined as the ITV plus a 5–7 mm margin in all directions.…”

Section: Methodsmentioning

confidence: 99%

Clinical Efficacy of Hypofractionated Proton Beam Therapy for Intrahepatic Cholangiocarcinoma

Kim

Woo

Lee

et al. 2022

Cancers

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Forty-seven patients with intrahepatic cholangiocarcinoma (IHCC) who received proton beam therapy (PBT) were analyzed to evaluate the clinical efficacy and safety of hypofractionated PBT in patients with inoperable or recurrent IHCC. The median prescribed dose of PBT was 63.3 GyE (range: 45–80 GyE) in 10 fractions, and the median duration of follow-up in all the patients was 18.3 months (range: 2.4–89.9 months). Disease progression occurred in 35 of the 47 (74.5%) patients; local, intrahepatic, and extrahepatic progression occurred in 5 (10.6%), 20 (42.6%), and 29 (61.7%) patients, respectively. The 2-year freedom from local progression (FFLP), progression-free survival (PFS), overall survival (OS) rates, and median time of OS were 86.9% (95% confidence interval [CI], 74.4–99.4%), 16.8% (95% CI, 4.3–29.3%), 42.7% (95% CI, 28.0–57.4%), and 21.9 months (95% CI, 16.2–28.3 months), respectively; grade ≥ 3 adverse events were observed in four (8.5%) patients. In selected patients with localized disease (no viable tumors outside of the PBT sites), the median time of OS was 33.8 months (95% CI, 5.4–62.3). These findings suggest that hypofractionated PBT is safe and could offer a high rate of FFLP and promising OS in patients with inoperable or recurrent IHCC.

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Section: Methodsmentioning

confidence: 99%

Clinical Efficacy of Hypofractionated Proton Beam Therapy for Intrahepatic Cholangiocarcinoma

Kim

Woo

Lee

et al. 2022

Cancers

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“…105 A single institution phase I feasibility study involving 6 patients with unresectable EHCC treated with a hypofractionated regimen of 60 Gy in 15 fractions following 6 to 8 cycles of systemic chemotherapy found the 12-month LC rate to be 80% without any observed limiting toxicities. 106 The pivotal ABC-02 established gemcitabine/cisplatin as the standard first-line treatment for advanced BTC. This phase III study, enrolling 410 patients with locally advanced or metastatic cholangiocarcinoma to receive either cisplatin/gemcitabine versus gemcitabine alone, showed OS was superior in the combination group without the added risk of toxicity.…”

Section: Unresectable Ehccmentioning

confidence: 99%

American Radium Society (ARS) Appropriate Use Criteria (AUC) for Extrahepatic Cholangiocarcinoma

Tchelebi¹,

Jethwa

Levy³

et al. 2022

American Journal of Clinical Oncology

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Although uncommon, extrahepatic cholangiocarcinoma (EHCC) is a deadly malignancy, and the treatment approaches remain controversial. While surgery remains the only cure, few patients are candidates for resection up front, and there are high rates of both local and distant failure following resection. Herein, we systematically review the available evidence regarding treatment approaches for patients with EHCC, including surgery, radiation, and chemotherapy. The evidence regarding treatment outcomes was assessed using the Population, Intervention, Comparator, Outcome, and Study design (PICOS) framework. A summary of recommendations based on the available literature is outlined for specific clinical scenarios encountered by providers in the clinic to guide the management of these patients.

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“…The STRONG study (NCT03307538) was the first prospective trial designed to evaluate the feasibility and toxicity of SBRT after first-line chemotherapy in patients with unresectable pCCa ( 16 , 17 ). Its secondary endpoints were local control, progression-free survival, overall survival, and quality of life (QoL).…”

Section: Introductionmentioning

confidence: 99%

“…Its secondary endpoints were local control, progression-free survival, overall survival, and quality of life (QoL). No dose-limiting toxicity was observed; at a median follow-up of 14 months, 12-month local control was 80%; and QoL did not change ( 16 ). An important aspect of the trial was study of the dosimetric impact of inter- and intra-fraction anatomical variations through daily acquisition of repeat CTs (rCT) with an in-room CT on-rails, both pre- and post- daily dose delivery.…”

Section: Introductionmentioning

confidence: 99%

Inter- and intrafraction dose variations in robotic stereotactic body radiation therapy (SBRT) for perihilar cholangiocarcinoma in the prospective phase I STRONG trial

Paronetto

Toom²,

Milder³

et al. 2023

Front. Oncol.

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Using fiducial-marker-based robotic respiratory tumor tracking, we treated perihilar cholangiocarcinoma patients in the STRONG trial with 15 daily fractions of 4 Gy. For each of the included patients, in-room diagnostic-quality repeat CTs (rCT) were acquired pre- and post-dose delivery in 6 treatment fractions to analyze inter- and intrafraction dose variations. Planning CTs (pCTs) and rCTs were acquired in expiration breath-hold. Analogous to treatment, spine and fiducials were used to register rCTs with pCTs. In each rCT, all OARs were contoured, and the target was rigidly copied from the pCT based on grey values. The rCTs acquired were used to calculate the doses to be delivered through the treatment-unit settings. On average, target doses in rCTs and pCTs were similar. However, due to target displacements relative to the fiducials in rCTs, 10% of the rCTs showed PTV coverage losses of >10%. Although target coverages had been planned below desired values in order to protect OARs, many pre-rCTs contained OAR constraint violations: 44.4% for the 6 major constraints. Most OAR dose differences between pre- and post-rCTs were not statistically significant. The dose deviations observed in repeat CTs represent opportunities for more advanced adaptive approaches to enhancing SBRT treatment quality.

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Stereotactic Body Radiation Therapy after Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: The STRONG Trial, a Phase I Safety and Feasibility Study

Cited by 9 publications

References 32 publications

Clinical Efficacy of Hypofractionated Proton Beam Therapy for Intrahepatic Cholangiocarcinoma

Clinical Efficacy of Hypofractionated Proton Beam Therapy for Intrahepatic Cholangiocarcinoma

American Radium Society (ARS) Appropriate Use Criteria (AUC) for Extrahepatic Cholangiocarcinoma

Inter- and intrafraction dose variations in robotic stereotactic body radiation therapy (SBRT) for perihilar cholangiocarcinoma in the prospective phase I STRONG trial

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