Abstract OT1-4-01: HIOB trial - Hypofractionated whole-breast irradiation preceded by intraoperative radiotherapy with electrons as anticipated boost
Bibliographic record
Abstract
Abstract ClinicalTrials.gov Identifier: NCT01343459 Brief background discussion: The commonly accepted standard fractionation schedule for whole breast irradiation (WBI) consists of 25fractionations with single fractional doses of 2 Gy, resulting in cumulative doses of 50 Gy to the whole breast. Hypofractionation trials from UK and Canada demonstrated a similar outcome in local control and cosmesis compared to conventional fractionation. The combination of IOERT boost and hypofractionation was not yet evaluated. Trial design: Prospective one-armed multi-center trial - ISIORT 01 Eligible patients are treated with hypofractionated whole breast irradiation (WBI) of 40.5 Gy in 2.7 Gy per fraction for 15 days, preceded by an intraoperative electron boost (IOERT) to the tumor bed of 10 Gy (90% isodose) during breast conserving surgery. Eligibility criteria: Inclusion criteria: Invasive breast cancer Age 35 years and older T1/T2, N1/N2, G1 - G3 Hormone receptor and Her 2 status: no limitations Exclusion criteria: Non-invasive breast cancer Age less than 35 years T3/T4, N2/N3 Neoadjuvant chemotherapy Aim of the study: To assess the effectiveness of IOERT in combination with hypofractionated WBI in terms of in-breast tumor control and cosmetic outcome, by matching or exceeding the best published results for annual LR rates in 3 different age groups in reference to an upper limit (exceeding = inferiority) and a lower limit (undershooting = superiority) which were estimated on the basis of the existing literature as follows: Age 35 – 40 years: Upper limit (best published evidence): 1.2 % (EORTC 22881- Boost trial) Lower limit (commonly expected dimension): 0.72 % (CONSORT trial) Age 41 – 50 years: Upper limit (best published evidence): 1.2 % (EORTC 22881- Boost trial) Lower limit (commonly expected dimension): 0.72 % (CONSORT trial) Age over 50 years: Upper limit (best published evidence): 0.7 % (EORTC 22881- Boost trial) Lower limit (commonly expected dimension): 0.4 % (START B trial) Primary endpoint: Proof of superiority or iso-effectiveness. Secondary endpoints: Acute toxicity (CTC- toxicity scoring system) and late toxicity (LENT SOMA scoring system), cosmetic results (Van Limbergen - Score), DFS, OS. Statistical methods: Sequential Probability Ratio Test (SPRT): As a consequence of best published analyses for this patient selection, stopping rules for annual local recurrence rates are defined as follows: Age group 35-40: H0: p1 <= 0.72% vs H1: p1 > 0.72% with p2 = 4.0% Age group 41-50: H0: p1 <= 0.72% vs H1: p1 > 0.72% with p2 = 2.4% Age group 51+: H0: p1 <= 0.4% vs H1: p1 > 0.4% with p2 = 1.4% H0-Hypothesis means no superiority to standard regimen. H1-Hypothesis means superiority of HIOB against best published evidence. Present accrual and target accrual: Start date: January 2011 Estimated enrollment: 1500 patients 542 patients recruited by March 2014 10 international institutions recruiting. Citation Format: Roland Reitsamer, Gerd Fastner, Michael Kopp, Felix Sedlmayer. HIOB trial - Hypofractionated whole-breast irradiation preceded by intraoperative radiotherapy with electrons as anticipated boost [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT1-4-01.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".