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Purpose The phase II component of RTOG 0631 assessed the feasibility and safety of spine radiosurgery (SRS) for localized spine metastases in a cooperative group setting. Materials and Methods Patients with 1-3 spine metastasis with a Numerical Rating Pain Scale (NRPS) score ≥ 5 received 16 Gy single fraction SRS. The primary endpoint was SRS feasibility: image-guidance RT (IGRT) targeting accuracy ≤ 2mm, target volume coverage > 90% of prescription dose, maintaining spinal cord dose constraints (10 Gy to ≤ 10% of the cord volume from 5-6mm above to 5-6mm below the target or absolute spinal cord volume < 0.35cc) and other normal tissue dose constraints. A feasibility success rate < 70% was considered unacceptable for continuation of the phase III component. Based on the one-sample exact binomial test with α=0.10 (1-sided), 41 patients were required. Acute toxicity was assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0. Results Sixty-five institutions were credentialed with spine phantom dosimetry and IGRT compliance. Forty-six patients were accrued, and 44 were eligible. There were 4 cervical, 21 thoracic and 19 lumbar sites. Median NRPS was 7 at presentation. Final pre-treatment rapid review was approved in 100%. Accuracy of image-guided SRS targeting was in compliance with the protocol in 95%. The target coverage and spinal cord dose constraint were in accordance with the protocol requirements in 100% and 97%. Overall compliance for other normal tissue constraints was per protocol in 74%. There were no cases of grade 4-5 acute treatment-related toxicity. Conclusion The phase II results demonstrate the feasibility and accurate use of SRS to treat spinal metastases, with rigorous quality control, in a cooperative group setting. The planned RTOG 0631 phase III component will proceed to compare pain relief and quality of life between SRS and external beam radiotherapy.

This trial was unable to adequately test the ability of beta-hydroxy beta-methylbutyrate, glutamine, and arginine to reverse or prevent lean body mass wasting among cancer patients. Possible contributing factors beyond the efficacy of the intervention were the inability of patients to complete an 8-week course of treatment and return in a timely fashion for follow-up assessment, and because the patients may have only had weight loss possible not related to cachexia, but other causes of weight loss, such as decreased appetite. However, there was a strong trend towards an increased body mass among patients taking the Juven compound using the secondary endpoint of AUC.

The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.