Ethics Approval and Consent to Participate
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants included in the study. This Phase III study was approved by the independent ethics committees including local independent committees at all participated study sites.
List of IRBs or IECs
Study Site # 01
Ethics Committee of Arkhangelsk Regional Clinical Cancer Dispensary, 145/1. Prospect Obvodniy Kanal, Arkhangelsk.
Chairperson: Alexandra Yuryevna Pankratyeva.
Study Site # 03
Ethics Committee of State Healthcare Institution Tula Regional Cancer Dispensary, 16, Ul. Yablochkova, Tula, 300053.
Chairperson: Svetlana Mikhailovna Kireeva.
Study Site # 05
Ethics Committee of State Budgetary Healthcare Institution Samara Regional Clinical Cancer Dispensary,
50, Ul. Solnechnaya, Samaram, 443031.
Chairperson: Tatyana Gennadyevna Zolotareva.
Study Site # 10
Ethics Committee of Federal State Budgetary Military Educational Institution of Higher Professional Education S.M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation,
6, Ul. Akademika Lebedeva, Saint Petersburg, 194044.
Chairperson: Sergey Borisovich Shustov.
Study Site # 11
Local Ethics Committee of Federal State Budgetary Institution N.N. Petrov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation,
68, Ul. Leningradskaya, Pesochniy, Saint Petersburg, 197758.
Chairperson: Evgeniy Vladimirovich Demin.
Study Site # 13
Ethics Committee of Moscow State Healthcare Institution Moscow City Oncology Hospital No. 62 of Healthcare Department of the City of Moscow,
27, Bldg. 1-26, P.O. Stepanovskoye, Krasnogorsk District, Moscow Region, 143423.
Chairperson: Svetlana Samoylovna Yudina.
Study Site # 14
Ethics Committee of State Budgetary Healthcare Institution Volgograd Regional Clinical Cancer Dispensary #1,78, Ul. Zemlyachki, Volgograd, 400138.
Chairperson: Sergey Alexeevich Zhuravlev.
Study Site # 16
Ethics Committee of Federal State Budgetary Institution N.N. Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences,
24, Kashirskoe shosse, Moscow, 115478.
Chairperson: Dina Zurabovna Kupchyan.
Study Site # 18
Ethics Committee of State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Cancer Dispensary,
42, Ul. Blykhera, Chelyabinsk, 454087.
Chairperson: Alexey Valeryevich Privalov.
Study Site # 21
Ethics Committee of State Budgetary Healthcare Institution Perm Regional Cancer Dispensary, 15, Ul. Baumana, Perm, 614066.
Chairperson: Yyuriiy Vladimirovich Kazakov.
Study Site # 22
Local Independent Ethics Committee of State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Hospital.
70, Ul. Vorovskogo, Chelyabinsk, 454076.
Chairperson: Vladimir Nikolaevich Kuzmin.
Study Site # 23
Local Ethics Committee of Regional Budgetary Healthcare Institution Kursk Regional Clinical Cancer Dispensary,
20, Ul. Pirogova, Kursk, 305035.
Chairperson: Vladimir Vladimirovich Khvostovoy.
Study Site # 24
Local Ethics Committee of State Budgetary Healthcare Institution Volgograd Regional Cancer Dispensary #3,
25, Ul. Komsomolskaya, Volzhskiy, Volgograd Region, 404130.
Chairperson: Viktoriya Viktorovna Zhavoronkova.
Study Site # 26
Local Ethics Committee of State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Cancer Dispensary, 31, Prospect Kalinina, Pyatigorsk, Stavropol Region, 357502.
Chairperson: Liana Vasilyevna Zagorodnykh.
Study Site # 27
Ethics Committee Budgetary Healthcare Institution of Omsk Region Clinical Cancer Dispensary, 9/1. Ul. Zavertyaeva, Omsk, 644013.
Chairperson: Oleg Vladimirovich Leonov.
Study Site # 29
Local Ethics Committee of State Budgetary Healthcare Institution Kursk Regional Cancer Dispensary of Healthcare Department of Kursk Region,
20, Ul. Pirogova, Kursk, 305035.
Chairperson: Vladimir Vladimirovich Khvostovoy.
Study Site # 30
Ethics Committee of State Autonomous Healthcare Institution Republican Clinical Cancer Dispensary of the Ministry of Healthcare of the Republic of Tatarstan,
29, Ul. Sibirskiy Tract, Kazan, Republic of Tatarstan, 420029.
Chairperson: Luiza Gaynutdinovna Karpenko.
Study Site # 34
Local Ethics Committee of Federal State Budgetary Educational Institution of Higher Professional Education N.P. Ogarev Mordovian State University,
26 a, Ul. Ulyanova, Saransk, Republic of Mordovia, 430032.
Chairperson: Natalya Viktorovna Shmyreva.
Study Site # 35
Local Ethics Committee of State Budgetary Healthcare Institution Orenburg Regional Clinical Cancer Dispensary,
11, Prospect Gagarina, Orenburg, 460021.
Chairperson: Alexander Gennadyevich Shekhtman.
Study Site # 36
Ethics Committee of State Budgetary Healthcare Institution of Higher Professional Education
I.P. Pavlov First Saint Petersburg State Medical University of the Ministry of Healthcare of the Russian Federation,
10, Ul. Roentgena, Saint Petersburg, 197101.
Chairperson: Edvin Eduardovich Zvartau.
Study Site # 43
Ethics Committee Shree Hospital
Shree Hospital, 5th floor Siddharth Mansion,
Nagar Road, Pune-411014, Maharashtra
Chairperson: Dr. Bhagwat Gunale
Study Site # 44
Ethics Committee
Bharath Hospital and Institute of Oncology
# 438, Outer ring road, Hebbal
Mysuru- 570017, Karnataka
Chairperson: Dr. Majunath C
Study Site # 50
Ethics Committee of Healthcare Institution Brest Regional Clinical Cancer Dispensary,
6, Ul. Meditsinskaya, Brest, Republic of Belarus, 224027.
Chairperson: Vitaliy Nikolaevich Lemetskiy.
Study Site # 53
Yashoda Academy of Medical Education & Research
8th floor, Yashoda Hospitals, behind harihara kalabhavan,
S P Road, Secunderabad-500003. Andhra Pradesh
Chairperson: Justice Sri. V. Bhaskar Rao
Study Site # 55
Marudhar Hospital Ethics Committee,
A-93-99, Basement, Singh bhoomi, Khatipura, Jaipur-302012,
Rajasthan
Chairperson: Ret. Col S. S. Rathore.
Study Site # 56
Institutional Ethics Committee Poona Medical Research Foundation
E4-C to E4-F, 4th Floor, Fifth Avenue Condominium,
Dhole Patil Road, Pune-411001, Maharashtra
Chairperson: Lt. Gen (Dr) S A Cruze
Study Site # 57
Institutional Ethics Committee-Govt. Medical College, Aurangabad
Panchakki Road, Aurangabad-431001, Maharashtra.
Chairperson: Dr S H Talib
Study Site # 58
Institutional Ethics Committee,
All India Institute of Medical Sciences Bhubaneshwar,
Sijua, Patrapada,
Bhubaneshwar, Orissa,7510 19
Chairperson: Dr. Suresh Chandra Dash
Study Site # 60
Shatabadi Hospital Ethics Committee
C/o Shatabdi Superspeciality Hospital, G21,
Suyoji City Centre, Opp. Mahamarg Bus Stand,
Mumbai Naka, Nasik – 422002, Maharashtra
Chairperson: Dr. Neelima Shafekar,
Study Site # 62
Ethics Committee of Vinnytsa Regional Clinical Cancer Dispensary, 84, Ul. Khmelnitskoye sjosse, Vinnytsa, Ukraine.
Chairperson: A.P. Kovalchuk
Study Site # 63
Ethics Committee of Zakarpattia Regional Clinical Cancer Dispensary, 2, Ul. Brodlokovicha, Uzhgorod, Ukraine.
Chairperson: O.S. Chemet
Study Site # 65
Ethics Committee of Municipal Treatment and Preventive Facility City Cancer Dispensary, 107B, Ul. Kalinina, Donetsk, Ukraine.
Chairperson: S.E. Bilousov
Study Site # 67
Institutional Ethics Committee,
Rajalakshmi Hospital
No. 21/1. Lakshmipura main road
Vidyaranyapura post
Bangalore, 560097, Karnataka
Chairperson: Ms. Chnadana T J
Study Site # 68
Ethics Committee of Municipal Healthcare Institution Makeevka City Hospital No. 2 12, Ul. Ferganskaya, Makeevka, Donetsk Region, Ukraine.
Chairperson: R.S. Titorenko
Study Site # 69
Ethics Committee of Municipal Institution Krivoy Rog Cancer Dispensary of Dnepropetrovsk Regional Council,
41, Dnepropetrovskoye shosse, Krivoy Rog, Ukraine.
Chairperson: O.V. Medvedkov
Study Site # 70
Ethics Committee of Municipal Healthcare Institution Kharkov Regional Clinical Cancer Center, 4, Ul. Lesoparkovaya, Kharkov, Ukraine.
Chairperson: D.V. Shapovalov.
Study Site # 71
Institutional Ethics Committee,
King George Medical University,
Lucknow-226003. UP
Chairperson: Prof. S P S Gaur
Study Site # 72
Institutional Ethics Committee of SMS Medical College & attached Hospitals.
Office of the Ethics Committee, Allergy clinic,
SMS Hospital, JLN Marg,
Jaipur-302004, Rajasthan
Chairperson: Dr. Shashi Singhvi
Study Site # 74
Institutional Ethics Committee S P Medical College & AG of Hospital, Bikaner.
Institutional Ethics Committee S P Medical College & AG of Hospital,
HRM cardiovascular Science & Research, Bikaner-334001, Rajasthan
Chairperson: Dr. G C Jain
Study Site # 76
HCG, Central Ethics Committee,
HCG Tower, P. Kalinga Rao Road,
Sampangirama Nagar Bangalore 560027, Karnataka
Chairperson: Dr. S G A Rao
Study Site # 77
Institutional Ethics Committee
Sri Ramachandra Medical College and Research Institute
No: 1, Ramachandra Nagar Porur, Chennai. 600116, Tamil Nadu
Chairperson: Dr. Nalini Ramamurthy
Study Site # 78
MAHE Ethics Committee
Mezzanine floor, KMC Old Library Building,
Madhava Nagar, Manipal-576104,
Udupi Dist., Karnataka
Chairperson: Dr. P. S Prakash
Study Site # 79
Institutional Ethics Committee
Meenakshi Mission Hospital and Research Centre
Lake Area, Melur Road, Madurai-625107, Tamil Nadu
Chairperson: Dr. Kumaresan
Study Site # 80
Institutional Ethics Committee
HCG Curie City Cancer Center,
# 44-1-1/3, Padavalarevu, Gunadala,
Vijayawada- 520004 Andhra Pradesh
Chairperson: Dr. V. N. N. Arun Kumar
Study Site # 81
Institutional Ethics Committee,
Sapthagiri Institute of Medical Sciences and Research Center
#15 Chikkasandra, Hesaraghatta Main road,
Bangalore, Karnataka 560090
Chairperson: Dr. Prasanna Kumar
Study Site # 83
Institutional Ethics Committee, KLE University
KLE University KLE Dr.PK Hospital and MRC
Nehru Nagar Belagavi
Karnataka - 590010
Chairperson: Dr. Subarna Roy
Study Site # 85
Institutional Ethics Committee
Noble Hospital, Room No. 701
No:4 Audiappa street, Alagappa road, Purasaiwakkam,
Chennai- 600084, Tamil Nadu
Chairperson: Dr. A. Vinoth Kumar
Study Site # 88
Institutional Ethics Committee,
RG Kar Medical College & Hospital,
1, Kshudiram Bose Sarani, Kolkata – 700004, West Bengal
Chairperson: Dr. Krishnageshu Ray
Study Site # 89
IPGME & R Research Oversight Committee,
Office of the dean,
Institute of Post graduate Medical Education and Research,
244 AJC Bose Road, Kolkata – 700020. West Bengal
Chairperson: Dr Avijit Hazara.
Study Site # 90
Ethics Committee N.S.C.B.C Research Institute
Netaji Subhash Chandra Bose Cancer Hospital,
3081, Nayabad, Kolkata-700094, West Bengal.
Chairperson: Dr. M L. Chakraborty
Study Site # 91
Institutional Ethics Committee,
NRS Medical College & Hospital,
138, AJC Bose Road, Kolkata – 700014, West Bengal
Chairperson: Prof (Dr). R. N Chattopadhyay
Study Site # 94
Institutional Ethics Committee of B. J. Govt. Medical
College & Sassoon General Hospital, Pune-411001, Maharashtra
Chairperson: Dr. Dayanand D. Shetty,
Study Site # 95
Ethics Committee Shalby Limited,
Shalby Hospitals, Opp. Karnavati Club, S. G. Highway,
Ahmedabad – 380015. Gujarat
Chairperson: Dr. Guruprasad Dumra
Study Site # 96
Amravati Ethics Committee
52/B, Shankar Nagar main road,
Amravathi-444606, Maharashtra
Chairperson: Dr. S.S. Pande
Study Site # 97
Manavata Clinical Research Institute Ethics Committee
Curie Manavata cancer centre,
Opp. Mahamarg busstand, Mumbai naka, Nashik-422004, Maharashtra
Chairperson: Prof. Shantanu Kale
Study Site # 98
Institutional Ethics Committee- Clinical Studies,
Site office Building,
Apollo Hospitals International Ltd, Bhat,
Gandhingar, Gujarat – 382428.
Chairperson: Dr. Mira Desai