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See detailQuality assurance of the EORTC 22043-30041 trial in post-operative radiotherapy in prostate cancer: Results of the Dummy Run procedure
Fenton, P. A.; Hurkmans, C.; GULYBAN, Akos ULg et al

in Radiotherapy & Oncology (2013)

Background and purpose: The EORTC 22043-30041 trial investigates the role of the addition of androgen suppression to post-operative radiotherapy in patients who have undergone radical prostatectomy. As ... [more ▼]

Background and purpose: The EORTC 22043-30041 trial investigates the role of the addition of androgen suppression to post-operative radiotherapy in patients who have undergone radical prostatectomy. As part of the quality assurance of radiotherapy (QART) a Dummy Run (DR) procedure was performed. Materials and method: The protocol included detailed and published delineation guidelines. Participating institutions digitally submitted radiotherapy treatment volumes and a treatment plan for a standard clinical case. Submissions were centrally reviewed using the VODCA software platform. Results: Thirty-eight submissions from thirty-one institutions were reviewed. Six were accepted without comments. Twenty-three were accepted with comments on one or more items: target volume delineation (22), OAR delineation (23), planning and dosimetry (3) or treatment verification (1). Nine submissions were rejected requiring resubmission, seven for target volume delineation reasons alone. Intervention to highlight the importance of delineation guidelines was made prior to the entry of the first patient in the trial. After this, a lower percentage of resubmissions was required. Conclusions: The EORTC 22043-30041 Dummy Run highlights the need for timely and effective QART in clinical trials. The variation in target volume and OAR definition demonstrates that clinical guidelines and radiotherapy protocols are not a substitute for QART procedures. Early intervention in response to the Dummy Run improved protocol understanding. © 2013 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailEORTC Radiation Oncology Group quality assurance platform: Establishment of a digital central review facility
Fairchild, A.; Aird, E.; Fenton, P. A. et al

in Radiotherapy & Oncology (2012), 103(3), 279-286

Objective: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of ... [more ▼]

Objective: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT. Methods: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. Results: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. Conclusions: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes. © 2012 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailToxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage i to III breast cancer (EORTC trial 22922/10925)
Matzinger, O.; Heimsoth, I.; Poortmans, P. et al

in Acta Oncologica (2010), 49(1), 24-34

Introduction. The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular (IM-MS) nodes Accrual ... [more ▼]

Introduction. The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular (IM-MS) nodes Accrual completed in January 2004 and first results are expected in 2012. We present the toxicity reported until year 3 after treatment. Patients and methods. At each visit, toxicity was reported but severity was not graded routinely. Toxicity rates and performance status (PS) changes at three years were compared by χ2 tests and logistic regression models in all the 3 866 of 4 004 patients eligible to the trial who received the allocated treatment. Results. Only lung (fibrosis; dyspnoea; pneumonitis; any lung toxicities) (4.3% vs. 1.3%; p < 0.0001) but not cardiac toxicity (0.3% vs. 0.4%; p = 0.55) significantly increased with IM-MS treatment. No significant worsening of the PS was observed (p = 0.79), suggesting that treatment-related toxicity does not impair patient's daily activities. Conclusions. IM-MS irradiation seems well tolerated and does not significantly impair WHO PS at three years. A follow-up period of at least 10 years is needed to determine whether cardiac toxicity is increased after radiotherapy. [less ▲]

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See detailAcute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991
Matzinger, O.; Duclos, F.; Bergh, A. V D et al

in European Journal of Cancer (2009), 45(16), 2825-2834

Introduction: This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score ... [more ▼]

Introduction: This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score) localised prostate cancer. We report acute toxicity (CTCAE v2) assessed weekly during RT in relation to radiation parameters. Patients and methods: Centres selected the RT dose (70, 74 or 78 Gy) and RT technique. Statistical significance is at 0.05. Results: Of 791 patients, 652 received 3D-CRT (70 Gy: 195, 74 Gy: 376, 78 Gy: 81) and 139 received IMRT (74 Gy: 28, 78 Gy: 111). During RT, grade 3 gastrointestinal (GI) and genitourinary (GU) toxicities were reported by7 (0.8%) and 50 (6.3%) patients, respectively. No grade 4 was reported. The risk of grade ≥2 GI toxicity increased significantly with increasing D50%-rectum (p = 0.004) and that of grade ≥2 GU toxicity correlated only to Dmax-bladder (p = 0.051). 3D-RT technique, increasing total dose and V95% >400 cc increased D50% and Dmax. One month after RT, only 14 patients (1.8%) reported grade 3 toxicity. AST did not seem to influence the risk of GU or GI acute toxicity. Conclusion: RT up to 78 Gy was well tolerated. Dmax-bladder and D50%-rectum influenced the risk of grade ≥2 GU toxicity and GI toxicity, respectively. Both were lower with IMRT but remained high for an irradiated RT volume > 400 cc for 3D-RT and for a dose of 78 Gy. Hormonal treatment did not influence acute toxicity. © 2009 Elsevier Ltd. All rights reserved. [less ▲]

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See detailQuality assurance in the 22991 EORTC ROG trial in localized prostate cancer: Dummy run and individual case review
Matzinger, O.; Poortmans, P.; Giraud, J.-Y. et al

in Radiotherapy & Oncology (2009), 90(3), 285-290

Introduction: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients ... [more ▼]

Introduction: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well. Materials and methods: CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review. Results: Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT. Conclusions: Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques. © 2008 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailEORTC-ROG expert opinion: Radiotherapy volume and treatment guidelines for neoadjuvant radiation of adenocarcinomas of the gastroesophageal junction and the stomach
Matzinger, O.; Gerber, E.; Bernstein, Z. et al

in Radiotherapy & Oncology (2009), 92(2), 164-175

Purpose: The Gastro-Intestinal Working Party of the EORTC Radiation Oncology Group (GIWP-ROG) developed guidelines for target volume definition in neoadjuvant radiation of adenocarcinomas of the ... [more ▼]

Purpose: The Gastro-Intestinal Working Party of the EORTC Radiation Oncology Group (GIWP-ROG) developed guidelines for target volume definition in neoadjuvant radiation of adenocarcinomas of the gastroesophageal junction (GEJ) and the stomach. Methods and materials: Guidelines about the definition of the clinical target volume (CTV) are based on a systematic literature review of the location and frequency of local recurrences and lymph node involvement in adenocarcinomas of the GEJ and the stomach. Therefore, MEDLINE was searched up to August 2008. Guidelines concerning prescription, planning and treatment delivery are based on a consensus between the members of the GIWP-ROG. Results: In order to support a curative resection of GEJ and gastric cancer, an individualized preoperative treatment volume based on tumour location has to include the primary tumour and the draining regional lymph nodes area. Therefore we recommend to use the 2nd English Edition of the Japanese Classification of Gastric Carcinoma of the Japanese Gastric Cancer Association which developed the concept of assigning tumours of the GEJ and the stomach to anatomically defined sub-sites corresponding respectively to a distinct lymphatic spread pattern. Conclusion: The GIWP-ROG defined guidelines for preoperative irradiation of adenocarcinomas of the GEJ and the stomach to reduce variability in the framework of future clinical trials. © 2009 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailPréoperative hyperfractionated accelerated radiotherapy (HART) in locally advanced rectal cancer (LARC) immediately followed by surgery. A prospective trial.
Coucke, Philippe ULg; Notter, M; Matter, M et al

in Radiotherapy & Oncology (2006), 79

Abstract Background and purpose: We aim to report on local control in a phase II trial on preoperative hyperfractionated and accelerated radiotherapy schedule (HART) in locally advanced resectable rectal ... [more ▼]

Abstract Background and purpose: We aim to report on local control in a phase II trial on preoperative hyperfractionated and accelerated radiotherapy schedule (HART) in locally advanced resectable rectal cancer (LARC). This fractionation schedule was designed to keep the overall treatment time (OTT) as short as possible. Patients and methods: This is a prospective trial on patients with UICC stages II and III rectal cancer. The patients were submitted to a total dose of 41.6 Gy, delivered in 2.5 weeks at 1.6 Gy per fraction twice a day with a 6-h interfraction interval. Surgery was performed within 1 week after the end of irradiation. Adjuvant chemotherapy was delivered in a subset of patients. Results: Two hundred and seventy nine patients were entered and 250 are fully assessable, with a median follow-up of 39 months. The 5-years actuarial local control (LC) rate is 91.7%. The overall survival (OS) is 59.6%. The freedom from disease relapse (FDR) is 71.5%. Downstaging was observed in 38% of the tumors. Conclusion: The actuarial LC at 5 years is 91.7%, although we are dealing with stages II–III LARC, mainly located in the lower rectum (median distanceZ5 cm). The pattern of failure is dominated by distant metastases and treatment intensification will obviously require a systemic approach. q 2006 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 79 (2006) 52–58. [less ▲]

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See detailDecreased local control following radiation therapy alone in early stage glottic carcinoma with anterior commissure extention.
Azria, D; COUCKE, Philippe ULg; Matzinger, O et al

in Sonderbande zur Strahlentherapie und Onkologie (2004), 2

Purpose: To assess the patterns of failure in the treatment of early-stage squamous cell carcinoma of the glottic larynx. Patients and Methods: Between 1983–2000, 122 consecutive patients treated for ... [more ▼]

Purpose: To assess the patterns of failure in the treatment of early-stage squamous cell carcinoma of the glottic larynx. Patients and Methods: Between 1983–2000, 122 consecutive patients treated for early laryngeal cancer (UICC T1N0 and T2N0) by radical radiation therapy (RT) were retrospectively studied. Male-to-female ratio was 106 : 16, and median age 62 years (35–92 years). There were 68 patients with T1a, 18 with T1b, and 36 with T2 tumors. Diagnosis was made by biopsy in 104 patients, and by laser vaporization or stripping in 18. Treatment planning consisted of three-dimensional (3-D) conformal RT in 49 (40%) patients including nine patients irradiated using arytenoid protection. A median dose of 70 Gy (60–74 Gy) was given (2 Gy/fraction) over a median period of 46 days (21–79 days). Median follow-up period was 85 months. Results: The 5-year overall, cancer-specific, and disease-free survival amounted to 80%, 94%, and 70%, respectively. 5-year local control was 83%. Median time to local recurrence in 19 patients was 13 months (5–58 months). Salvage treatment consisted of surgery in 17 patients (one patient refused salvage and one was inoperable; total laryngectomy in eleven, and partial laryngectomy or cordectomy in six patients). Six patients died because of laryngeal cancer. Univariate analyses revealed that prognostic factors negatively influencing local control were anterior commissure extension, arytenoid protection, and total RT dose < 66 Gy. Among the factors analyzed, multivariate analysis (Cox model) demonstrated that anterior commissure extension, arytenoid protection, and male gender were the worst independent prognostic factors in terms of local control. Conclusion: For early-stage laryngeal cancer, outcome after RT is excellent. In case of anterior commissure extension, surgery or higher RT doses are warranted. Because of a high relapse risk, arytenoid protection should not be attempted. [less ▲]

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