Phase II Trial Comparing Stereotactic Body Radiotherapy Versus Active Surveillance for Oligometastatic Adenoid Cystic Carcinoma
SABR Oligo-ACC Trial: A Randomized Phase II Trial Comparing Stereotactic Body Radiotherapy Versus Active Surveillance for Oligometastatic Adenoid Cystic Carcinoma
The SABR Oligo-ACC Trial is a randomized phase II study comparing early initiation of SBRT to all metastases versus active surveillance in patients with oligometastatic ACC.
By directly comparing these strategies, the study will determine whether treating limited metastatic disease at the earliest opportunity translates into improved progression-free survival, while also evaluating overall survival, local control, subsequent patterns of progression, time to systemic therapy, toxicity and quality of life.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The oligometastatic state represents a potentially distinct phase of cancer dissemination in which eradication of all visible metastatic disease may alter subsequent disease progression. Prospective randomized trials in several solid tumors have provided evidence supporting this paradigm. In the phase II SABR-COMET trial, patients with a controlled primary tumor and 1-5 metastases randomized to comprehensive SABR had longer overall survival than those receiving standard treatment alone (median 41 vs 28 months; HR 0.57). Long-term follow-up demonstrated a 5-year overall survival of 42.3% with SABR versus 17.7% with standard treatment. There is robust prospective evidence that metastasis-directed therapy can modify the course of oligometastatic disease; however, their findings cannot be directly extrapolated to adenoid cystic carcinoma (ACC), which has distinct tumor biology and natural history.
A recent retrospective study has demonstrated that patients with oligometastatic ACC had more favorable outcomes than patients with higher metastatic burden, and that early initiation of local treatment was associated with improvement in PFS. However, these observations are subject to selection and other inherent biases of retrospective studies and cannot establish that local ablative therapy itself improves survival or progression-free survival.
The SABR Oligo-ACC Trial is therefore proposed as a randomized, phase II study comparing early initiation of SBRT to all metastases versus active surveillance in patients with oligometastatic ACC.
90 patients with histologically confirmed ACC of any primary site along with oligometastatic disease (1-5 active radiologically detectable extracranial metastatic lesions involving one or more organs) will be participating in this study.
They will be randomized (computer-generated randomization system) in a 1:1 ratio to either Stereotactic Body Radiotherapy (SBRT) or Active Surveillance.
Arm A=SBRT to all oligometastasis Arm B =Active surveillance Overall survival (OS), Progression Free Survival (PFS), Local Control of metatstatic lesion, SBRT toxicity (CTCAE version 5.0) and Quality of life (EORTC QLQ C-30) will be assessed at different timelines.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age ≥18 years.
- Histologically confirmed adenoid cystic carcinoma (ACC) of any primary site.
- Oligometastatic disease, defined as 1-5 active radiologically detectable extracranial metastatic lesions involving one or more organs.
- Both synchronous/metachronous/ oligoprogressive oligometastatic disease are eligible.
- All active metastatic lesions must be amenable to comprehensive SBRT.
- Controlled primary tumor or loco-regional disease amenable to sugery and radiotherapy
- ECOG Performance Status 0-2.
- Adequate organ function to undergo SBRT and protocol-specified investigations.
- Ability and willingness to comply with study assessments and follow-up.
- Written informed consent.
Exclusion Criteria:
- >5 active metastatic lesions at the time of randomization.
- Any active metastatic lesion that is not safely amenable to SBRT according to protocol-defined dose and normal-tissue constraints.
- Uncontrolled or progressive primary/regional disease requiring immediate local treatment, except for newly diagnosed synchronous disease that has been appropriately managed and is suitable for protocol randomization.
- Symptomatic metastatic disease requiring immediate systemic therapy, surgery or palliative radiotherapy.
- Metastatic disease associated with an oncological emergency, including impending pathological fracture, spinal cord compression, unstable spinal disease, major airway compromise, major vascular compromise or other condition requiring urgent intervention.
- Active untreated CNS metastases requiring surgery, SRS or other CNS-directed treatment.
- Oligoinduced disease during active systemic therapy.
- Concurrent systemic anticancer therapy at randomization or during protocol-defined SBRT.
- Previous radiotherapy that precludes safe delivery of protocol-specified SBRT because of cumulative dose constraints.
- Another active malignancy requiring treatment or likely to interfere with assessment of ACC-related outcomes.
- Uncontrolled intercurrent illness or medical condition that would preclude protocol treatment or follow-up.
- Pregnancy or lactation.
- Inability or unwillingness to provide informed consent or comply with study procedures.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: SBRT ARM
Comprehensive SBRT to all active metastatic lesions that are safely amenable to stereotactic treatment. |
SBRT will be delivered using image-guided, highly conformal radiotherapy with appropriate immobilization and image guidance, using institutionally validated dose-fractionation schedules based on the site, size, number, and proximity of lesions to critical organs. Treatment will be planned to achieve ablative tumor doses while respecting established organ-at-risk constraints. SBRT will preferably be completed within 1-2 weeks. |
|
Žádný zásah: Active surveillance
Observation with scheduled clinical and radiological assessment, with initiation of local or systemic treatment if clinically indicated. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-free survival (PFS)
Časové okno: 5 years
|
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse. |
5 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Místní ovládání
Časové okno: 5 let
|
5 let
|
|
|
Overall survival (OS)
Časové okno: assessed at follow up visits 1 to 10 years
|
The length of time from the start of treatment for the disease, that patients diagnosed with the disease are still alive. |
assessed at follow up visits 1 to 10 years
|
|
Radiation Toxicity
Časové okno: 5 years
|
using CTCAE version 5.0. : Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living . Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
5 years
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.
- Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.
- Phillips R, Shi WY, Deek M, Radwan N, Lim SJ, Antonarakis ES, Rowe SP, Ross AE, Gorin MA, Deville C, Greco SC, Wang H, Denmeade SR, Paller CJ, Dipasquale S, DeWeese TL, Song DY, Wang H, Carducci MA, Pienta KJ, Pomper MG, Dicker AP, Eisenberger MA, Alizadeh AA, Diehn M, Tran PT. Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):650-659. doi: 10.1001/jamaoncol.2020.0147.
- Geiger JL, Ismaila N, Beadle B, Caudell JJ, Chau N, Deschler D, Glastonbury C, Kaufman M, Lamarre E, Lau HY, Licitra L, Moore MG, Rodriguez C, Roshal A, Seethala R, Swiecicki P, Ha P. Management of Salivary Gland Malignancy: ASCO Guideline. J Clin Oncol. 2021 Jun 10;39(17):1909-1941. doi: 10.1200/JCO.21.00449. Epub 2021 Apr 26.
- Lorini L, Ardighieri L, Bozzola A, Romani C, Bignotti E, Buglione M, Guerini A, Lombardi D, Deganello A, Tomasoni M, Bonini SA, Sigala S, Farina D, Ravanelli M, Bossi P. Prognosis and management of recurrent and/or metastatic head and neck adenoid cystic carcinoma. Oral Oncol. 2021 Apr;115:105213. doi: 10.1016/j.oraloncology.2021.105213. Epub 2021 Feb 9.
- Tyan K, Bae JE, Lorch JH, Margalit DN, Tishler RB, Huynh MA, Jo VY, Haddad RI, Chau NG, Hanna GJ, Schoenfeld JD. Oligometastatic adenoid cystic carcinoma: Correlating tumor burden and time to treatment with outcomes. Head Neck. 2022 Mar;44(3):722-734. doi: 10.1002/hed.26964. Epub 2021 Dec 19.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AIIMS SABR Oligo-ACC Trial
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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