RTOG quality assurance guidelines for clinical trials using hyperthermia for deep-seated malignancy

Sapozink, Michael D.; Corry, Peter M.; Kapp, Daniel S.; Myerson, Robert J.; Dewhirst, Mark W.; Emami, Bahman; Herman, TS; Prionas, Stavros D.; Ryan, Thomas P.; Samulski, Thaddeus V.; Sapareto, Stephen A.; Shrivastava, Prakash N.; Stauffer, Paul R.; Waterman, Frank M.

doi:10.1016/0360-3016(91)90212-m

Cited by 47 publications

(13 citation statements)

References 19 publications

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“…Note that there were eight dogs (four in each thermal dose group) that did not finish all planned hyperthermia treatments due to various reasons. The median (interquartile range) number of temperature points was 21 (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27). There was excellent temperature discrimination between thermal dose groups (Fig.…”

Section: Resultsmentioning

confidence: 98%

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Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Thrall

LaRue

Yu³

et al. 2005

Clinical Cancer Research

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Purpose:To test that prospective delivery of higher thermal dose is associated with longer tumor control duration. Experimental Design: 122 dogs with a heatable soft tissue sarcoma were randomized to receive a low (2-5 CEM43jCT90) or high (20-50 CEM43jCT90) thermal dose in combination with radiotherapy. Most dogs (90%) received four to six hyperthermia treatments over 5 weeks. Results: In the primary analysis, median (95% confidence interval) duration of local control in the low-dose group was1.2 (0.7-2.1) years versus1.9 (1.4-3.2) years in the high-dose group (log-rank P = 0.28). The probability (95% confidence interval) of tumor control at 1 year in the low-dose versus high-dose groups was 0.57 (0.43-0.70) versus 0.74 (0.62-0.86), respectively. Using multivariable procedure, thermal dose group (P = 0.023), total duration of heating (P = 0.008), tumor volume (P = 0.041), and tumor grade (P = 0.027) were significantly related to duration of local tumor control. When correcting for volume, grade, and duration of heating, dogs in the low-dose group were 2.3 times as likely to experience local failure. Conclusions: Thermal dose is directly related to local control duration in irradiated canine sarcomas. Longer heating being associated with shorter local tumor control was unexpected. However, the effect of thermal dose on tumor control was stronger than for heating duration. The heating duration effect is possibly mediated through deleterious effects on tumor oxygenation. These results are the first to show the value of prospectively controlled thermal dose in achieving local tumor control with thermoradiotherapy, and they establish a paradigm for prescribing thermoradiotherapy and writing a thermal prescription.

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Section: Resultsmentioning

confidence: 98%

“…Tumors were imaged using computed tomography and thermometry catheters were placed according to Radiation Therapy Oncology Group guidelines (27,28). Hyperthermia was induced using scanning spiral or annular array microwave applicators operating between 140 and 433 MHz.…”

Section: Methodsmentioning

confidence: 99%

Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Thrall

LaRue

Yu³

et al. 2005

Clinical Cancer Research

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“…In three follow-up papers the RTOG published guidelines to address quality assurance issues pertaining to deep tissue. (115) RTOG quality assurance guidelines for interstitial hyperthermia (116) and ultrasound. (117) Recently, leading experts in the United States published a review of the competencies and tasks used in a hyperthermia clinic.…”

Section: Challenges To Clinical Implementationmentioning

confidence: 99%

Hyperthermia, Radiation and Chemotherapy: The Role of Heat in Multidisciplinary Cancer Care

Hurwitz

Stauffer

2014

Seminars in Oncology

119

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“…RTOG guidelines were followed (Dewhirst et al 1990, Sapozink et al 1991, but in most instances more stringent criteria were applied. The thermometry goals were to sample the temperature pro® le across the major axis of the tumour (two catheters minimum), through the tumour/normal tissue interface, and at a deep margin of the tumour.…”

Section: T Hermometrymentioning

confidence: 99%

Using units of CEM 43°C T₉₀, local hyperthermia thermal dose can be delivered as prescribed

Thrall

Rosner

Azuma

et al. 2000

International Journal of Hyperthermia

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A randomized study was designed in dogs with spontaneous soft tissue sarcomas to gain information about the relationship between hyperthermia dose and outcome. The study compared two levels of thermal dose applied to dogs with heatable tumours, so it was necessary to deliver either a low (2-5 CEM 43 degrees C T90) or high (20-50 CEM 43 degrees C T90) thermal dose as precisely as possible. It was also desirable to have similar numbers of hyperthermia treatments in each thermal dose group. Identification of heatable tumours and randomization to high or low heat dose group was done during the first hyperthermia treatment. This was readily accomplished using mapping of temperatures in thermometry catheters, manual recording of thermal data, and visual inspection of raw thermal data with subsequent adjustment of the duration of the hyperthermia treatment. An analysis of precision of thermal dose delivery was conducted after approximately 50% of projected accrual had been met in a randomized phase III assessment of thermal dose effect. Fifty-four dogs were eligible for randomization; in 48 dogs the tumour was deemed heatable according to predetermined temperature criteria applied during the first heat treatment. Twenty-four dogs were randomized to the high heat dose group, and 24 to the low heat dose group. Median (range) total thermal dose for dogs in the high dose group was 43.5 CEM 43 degrees C T90 (16.4-66.6) compared to 3.2 CEM 43 degrees C T90 (2.1-4.6) for dogs in the low dose group. There was no overlap of thermal doses between groups. Thus, thermal dose could be delivered accurately, being within the predetermined range in 47 of the 48 dogs. Thermal dose quantified as CEM 43 degrees C T50, however, did overlap between groups and the clinical significance of this finding will not be known until outcome data are analysed. Most dogs in both groups received five hyperthermia treatments. Median (range) treatment duration for dogs in the high dose group was 300 min (147-692) compared to III min (51-381) for dogs in the low dose group. Relatively simple but accurate methods of delivering prescribed thermal dose as described herein will aid the translation of clinical hyperthermia from the research setting into more general practice once the characteristics of the relationship between hyperthermia dose and outcome are understood.

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RTOG quality assurance guidelines for clinical trials using hyperthermia for deep-seated malignancy

Cited by 47 publications

References 19 publications

Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Hyperthermia, Radiation and Chemotherapy: The Role of Heat in Multidisciplinary Cancer Care

Using units of CEM 43°C T₉₀, local hyperthermia thermal dose can be delivered as prescribed

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RTOG quality assurance guidelines for clinical trials using hyperthermia for deep-seated malignancy

Cited by 47 publications

References 19 publications

Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Thermal Dose Is Related to Duration of Local Control in Canine Sarcomas Treated with Thermoradiotherapy

Hyperthermia, Radiation and Chemotherapy: The Role of Heat in Multidisciplinary Cancer Care

Using units of CEM 43°C T90, local hyperthermia thermal dose can be delivered as prescribed

Contact Info

Product

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Using units of CEM 43°C T₉₀, local hyperthermia thermal dose can be delivered as prescribed