ArticleRadiation oncology (London, England)2016
Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03).
Article in Radiation oncology (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01498835 (Phase 1 Trial of Concurrent Sunitinib and Radiation Therapy as Preoperative Treatment for Locally Advanced or Recurrent Soft Tissue Sarcoma.), which is not on this map. Cited by 12 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1 Trial of Concurrent Sunitinib and Radiation Therapy as Preoperative Treatment for Locally Advanced or Recurrent Soft Tissue Sarcoma.
Who cites it
12 citing papers in PubMed, 29 citations in OpenAlex.
- Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Article
- Case report: Pathological complete response to perioperative treatment of radiotherapy combined with angiogenesis inhibitor in a patient with pleomorphic liposarcoma.Frontiers in oncology · 2023Article
- Preoperative Radiation for Soft Tissue Sarcomas: How Much Is Needed?Current treatment options in oncology · 2022Review
- Article
- Neoadjuvant Treatment Options in Soft Tissue Sarcomas.Cancers · 2020Review
- Impact of preoperative treatment on the CINSARC prognostic signature: translational research results from a phase 1 trial of the German Interdisciplinary Sarcoma Group (GISG 03).Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2020Article
- Anti-Angiogenic Agents in Management of Sarcoma Patients: Overview of Published Trials.Frontiers in oncology · 2020Review
- Coronavirus Disease (COVID-19) Outbreak: Hypofractionated Radiotherapy in Soft Tissue Sarcomas as a Valuable Option in the Environment of Limited Medical Resources and Demands for Increased Protection of Patients.Frontiers in oncology · 2020Article
- Role of stereotactic body radiation therapy for the management of renal cell carcinoma: tailoring treatment in the era of the "embarrassment of riches".Annals of translational medicine · 2019Article
- Trabectedin and RAdiotherapy in Soft Tissue Sarcoma (TRASTS): Results of a Phase I Study in Myxoid Liposarcoma from Spanish (GEIS), Italian (ISG), French (FSG) Sarcoma Groups.EClinicalMedicine · 2019Article
- Safely combining trabectedin with radiotherapy to treat myxoid liposarcoma.EClinicalMedicine · 2019Article
- The clinical application of angiostatic therapy in combination with radiotherapy: past, present, future.Angiogenesis · 2017Review
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExperimental data demonstrated that concurrent anti-angiogenic treatment with sunitinib may improve the efficacy of radiation therapy (RT). Here we report the results of a phase I trial performed within the German Interdisciplinary Sarcoma Group (GISG-03) of combined sunitinib and RT for neoadjuvant treatment of locally advanced soft tissue sarcoma (STS).
methodsThe primary endpoint of the study was to explore the recommended dose of sunitinib combined with RT for subsequent trials. Treatment response, postoperative complications after tumor resection and toxicity according to CTCAE 4.0 were secondary endpoints. The study used a 3 + 3 design. Patients received either 25 mg (dose level 1) or 37.5 mg (dose level 2) sunitinib two weeks prior to and throughout RT (28 × 1.8 Gy). Surgery was scheduled 5-8 weeks after completion of neoadjuvant treatment. STUDY REGISTRATION: NCT01498835.
resultsSix patients were enrolled in dose level 1 and three patients in dose level 2. Median tumor size was 11 cm. Tumors were located in the retroperitoneum (4/9), lower leg (3/9) or trunk (2/9). At dose level 1, 1/6 patients developed dose limiting lymphopenia. At dose level 2, no patient developed dose limiting toxicity. Most frequent toxicities were hematological (8/9) and oral (5/9). Dose adjustments of sunitinib were necessary in 5/9 patients. All patients received full dose RT and underwent tumor resection (8/9 R0 and 1/9 R1). Local toxicity of RT did not exceed Grade 2. 2/9 patients had postoperative complications requiring re-intervention. Treatment response according to RECIST was as follows: partial response 1/9, stable disease 7/9, and progressive disease 1/9. Pathological examination revealed ≥ 95 % tumor necrosis in 3/9 resected specimens.
conclusionsCombined sunitinib and RT was tolerable as neoadjuvant treatment for locally advanced STS patients regardless of tumor localization. The recommended sunitinib dose for subsequent trials is 37.5 mg.
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