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PLANNING PHASE 2 MULTICENTER RANDOMIZED TRIAL OF NEOADJUVANT CHEMO-RADIOTHERAPY FOLLOWED BY D2 GASTRECTOMY AND ADJUVANT CHEMOTHERAPY FOR LOCALLY ADVANCED GASTRIC CANCER

https://doi.org/10.21294/1814-4861-2016-15-2-12-20

Abstract

Introduction. The prognosis for surgical treatment of locally advanced gastric cancer remains disappointing. Neoadjuvant chemo-radiation therapy is relatively new and the least researched method of treatment, it is attracting more and more attention, mainly abroad in recent years. The aims of neoadjuvant therapy is the earliest start of systemic therapy, damage of the primary tumor and regional metastases, an increase in the percentage of radical operations, improving treatment outcome. Material and methods. The planning study is a multicenter, randomized clinical phase II trial. Patients of the first (experimental) group will be treated as the followes: neoadjuvant chemo-radiotherapy (total tumor dose of 46 Gy in 23 fractions with the concurrent modified CapOX scheme) followed by D2 gastrectomy and adjuvant chemotherapy. Patients of the second (control) group will be treated with D2 gastrectomy and adjuvant chemotherapy. Adjuvant chemotherapy will be carried out under the following schemes (optional for the researchers): CapOX or FOLFOX. Toxicity evaluation of neoadjuvant chemo-radiotherapy and adjuvant chemotherapy will be conducted with NCI CTC Toxicity Scale Version 3.0. The main objectives of the trial are to assess the safety and immediate effectiveness of neoadjuvant chemo-radiotherapy according to the criteria of the frequency and severity of postoperative complications and mortality, and tumor response. We are planning to include 80 patients with morphologically confirmed gastric cancer сT2–4N1–3, сT3–4N0–3; М0. The proposed trial will be carried out in accordance with the principles of the Helsinki Declaration, it has been approved by local ethic committees of the participated institutions. Results. As a result of this multicenter randomized trial it is planned to show the reproducibility of obtained in MRRC and a number of foreign centers results – that is, the safety and high immediate effectiveness of neoadjuvant chemo-radiotherapy in patients with locally advanced gastric cancer. Conclusion. If we reach the goals of the planning trial, the results would allow to reasonably recommend the start of large international phase III trials for the final evaluation of the proposed neoadjuvant treatment as a standard one in patients with locally advanced gastric cancer.

About the Authors

V. Yu. Skoropad
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

MD, PSc, Leading Researcher, Department of Radiation and Surgical Treatment of Diseases of the Abdominal Region, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation). SPIN-code: 2283-1111.



S. G. Afanasyev
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PSc, Chief Researcher, Professor, Thoracic and Abdominal Department, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 9206-3037.



S. V. Gamayunov
Republican Clinical Oncology Center, Ministry of Health of the Republic of Chuvashia, Cheboksary
Russian Federation

MD, PhD, Deputy of Chief Physician for Surgery, Republican Clinical Oncology Center, Republic of Chuvashia (Cheboksary, Russia). SPIN-code: 9828-9522.



T. A. Agababyan
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

MD, PhD, Senior Research, Department of Computed Tomography, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation).  SPIN-code: 5752-3393.



M. Yu. Volkov
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PhD, Surgeon, Thoracic and Abdominal Department, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 8052-9941.



S. A. Glushchenko
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PhD, Pathologist, Department of Pathomorphology, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 2380-3406.



L. V. Evdokimov
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

MD, PhD, Senior Research, Department of Radiation and Surgical Treatment of Diseases of the Abdominal Region, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation). SPIN-code: 2121-6722.



K. S. Korchagina
Republican Clinical Oncology Center, Ministry of Health of the Republic of Chuvashia, Cheboksary
Russian Federation

Pathologist, Republican Clinical Oncology Center, Republic of Chuvashia (Cheboksary, Russia). SPIN-code: 8978-0619.



S. A. Mozerov
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

MD, PSc, Head of Clinico-Morphology Department, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation).SPIN-code:1604-0795.



O. A. Mikhaylova
Republican Clinical Oncology Center, Ministry of Health of the Republic of Chuvashia, Cheboksary
Russian Federation

Radiologist, Republican Clinical Oncology Center, Republic of Chuvashia (Cheboksary, Russia).



N. O. Popova
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PhD, Senior Research, Department of Chemotherapy, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 7672-1029.



G. O. Rukhadze
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

Research, Department of Radiation and Surgical Treatment of Diseases of the Abdominal Region, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation). SPIN-code: 3539-4184.



E. N. Samtsov
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PSc, Radiologist, Department of Ray Diagnostic Methods, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 3136-7543.



M. A. Safonova
Republican Clinical Oncology Center, Ministry of Health of the Republic of Chuvashia, Cheboksary
Russian Federation

Radiologist, Head of the Department, Republican Clinical Oncology Center, Republic of Chuvashia (Cheboksary, Russia).



A. A. Sveklova
Republican Clinical Oncology Center, Ministry of Health of the Republic of Chuvashia, Cheboksary
Russian Federation

Head of the Radiology Department,, Republican Clinical Oncology Center, Republic of Chuvashia (Cheboksary, Russia).



Zh. A. Startseva
Tomsk Cancer Research Institute, Tomsk
Russian Federation

MD, PSc, Head of the Radiology Department, Tomsk Cancer Research Institute (Tomsk, Russia). SPIN-code: 8121-0310.



L. N. Titova
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

Radiologist, Department of Radiation Therapy, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation).



Z. K. Yakushina
A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, 4, Korolev Street, 249031-Obninsk, Kaluga region, Russia.
Russian Federation

lead coder, Department of Radiation and Surgical Treatment of Diseases of the Abdominal Region, A.F. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Centre (Obninsk, Kaluga region, Russian Federation)



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For citations:


Skoropad V.Yu., Afanasyev S.G., Gamayunov S.V., Agababyan T.A., Volkov M.Yu., Glushchenko S.A., Evdokimov L.V., Korchagina K.S., Mozerov S.A., Mikhaylova O.A., Popova N.O., Rukhadze G.O., Samtsov E.N., Safonova M.A., Sveklova A.A., Startseva Zh.A., Titova L.N., Yakushina Z.K. PLANNING PHASE 2 MULTICENTER RANDOMIZED TRIAL OF NEOADJUVANT CHEMO-RADIOTHERAPY FOLLOWED BY D2 GASTRECTOMY AND ADJUVANT CHEMOTHERAPY FOR LOCALLY ADVANCED GASTRIC CANCER. Siberian journal of oncology. 2016;15(2):12-20. (In Russ.) https://doi.org/10.21294/1814-4861-2016-15-2-12-20

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ISSN 1814-4861 (Print)
ISSN 2312-3168 (Online)