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Salvage Radiotherapy clinical trials

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NCT ID: NCT05781217 Recruiting - Prostate Cancer Clinical Trials

Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

URONCOR 06-24
Start date: March 14, 2023
Phase: Phase 3
Study type: Interventional

The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score > 7, stage pT3-T4, PSA > 1 ng/mL in cases with biochemical recurrence [BCR], and PSA doubling time [PSA-DT] < 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels > 1 ng/mL at recurrence. The results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT. In line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial. SRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, we intend to perform a multicentre, phase III trial to define the optimal duration of ADT (6 vs. 24 months).

NCT ID: NCT03990532 Recruiting - Esophageal Cancer Clinical Trials

Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer

NCT ID: NCT02976402 Recruiting - SBRT Clinical Trials

Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

SHARP
Start date: November 2016
Phase: Phase 1
Study type: Interventional

The present phase I trial evaluates the feasibility of a postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Eligible patients for this study are those with: - Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy) - Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement - Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL) - Life expectancy: 10 years - ECOG performance status of 0 -1 - No distant metastases, based on the following workup within 60 days prior to registration - Magnetic resonance imaging (MRI) of the pelvis - PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence - Patients can be on androgen deprivation therapy - Ability to understand and willingness to sign a study-specific informed consent prior to study. Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.