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Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial.

Müller AC, Zips D, Heinrich V, Lamprecht U, Voigt O, Burock S, Budach V, Wust P, Ghadjar P - Radiat Oncol (2015)

Bottom Line: These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT.The study hypothesis is that radio-thermotherapy is a safe and feasible salvage treatment modality.The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. arndt-christian.mueller@med.uni-tuebingen.de.

ABSTRACT

Background: Current studies on salvage radiotherapy (sRT) investigate timing, dose-escalation and anti-hormonal treatment (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT. A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated radiotherapy.

Methods: The study hypothesis is that radio-thermotherapy is a safe and feasible salvage treatment modality. The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4. Feasibility is defined by number of hyperthermia treatments (n ≥ 7) and feasibility of radiotherapy according to protocol. Target volume delineation is performed according to the EORTC guidelines. Radiation treatment is administered with single doses of 2 Gy 5×/week to a total dose of 70 Gy. Regional hyperthermia is given 2×/week to a total of 10 treatments.

Results: European centres participate in the phase II trial using intensity modulated RT (IMRT) or volumetric modulated arc technique (VMAT). The initiating centres were participants of the SAKK 09/10 study, where the same patient criteria and target volume definition (mandatory successful performed dummy run) were applied insuring a high standardisation of the study procedures.

Conclusions: The introduced phase II study implements highly precise image-guided radiotherapy and regional hyperthermia. If the phase II study is found to be safe and feasible, a multicenter phase III study is planned to test whether the addition of regional hyperthermia to dose-intensified sRT improves biochemical control.

No MeSH data available.


Related in: MedlinePlus

Design of the phase II study of radio-thermotherapy for biochemical recurrent prostate cancer
© Copyright Policy - open-access
Related In: Results  -  Collection

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Fig1: Design of the phase II study of radio-thermotherapy for biochemical recurrent prostate cancer

Mentions: The study is designed as a multicentre prospective phase II study. An outline of the study procedures is given in Fig. 1.Fig. 1


Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial.

Müller AC, Zips D, Heinrich V, Lamprecht U, Voigt O, Burock S, Budach V, Wust P, Ghadjar P - Radiat Oncol (2015)

Design of the phase II study of radio-thermotherapy for biochemical recurrent prostate cancer
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4493985&req=5

Fig1: Design of the phase II study of radio-thermotherapy for biochemical recurrent prostate cancer
Mentions: The study is designed as a multicentre prospective phase II study. An outline of the study procedures is given in Fig. 1.Fig. 1

Bottom Line: These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT.The study hypothesis is that radio-thermotherapy is a safe and feasible salvage treatment modality.The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Eberhard Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. arndt-christian.mueller@med.uni-tuebingen.de.

ABSTRACT

Background: Current studies on salvage radiotherapy (sRT) investigate timing, dose-escalation and anti-hormonal treatment (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT. A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated radiotherapy.

Methods: The study hypothesis is that radio-thermotherapy is a safe and feasible salvage treatment modality. The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4. Feasibility is defined by number of hyperthermia treatments (n ≥ 7) and feasibility of radiotherapy according to protocol. Target volume delineation is performed according to the EORTC guidelines. Radiation treatment is administered with single doses of 2 Gy 5×/week to a total dose of 70 Gy. Regional hyperthermia is given 2×/week to a total of 10 treatments.

Results: European centres participate in the phase II trial using intensity modulated RT (IMRT) or volumetric modulated arc technique (VMAT). The initiating centres were participants of the SAKK 09/10 study, where the same patient criteria and target volume definition (mandatory successful performed dummy run) were applied insuring a high standardisation of the study procedures.

Conclusions: The introduced phase II study implements highly precise image-guided radiotherapy and regional hyperthermia. If the phase II study is found to be safe and feasible, a multicenter phase III study is planned to test whether the addition of regional hyperthermia to dose-intensified sRT improves biochemical control.

No MeSH data available.


Related in: MedlinePlus