Clinical Trial

Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001

Christian Marth, Rafal Tarnawski, Alexandra Tyulyandina, Sandro Pignata, Lucy Gilbert, Diego Kaen, M Jesús Rubio, Sophia Frentzas, Mario Beiner, Manuel Magallanes-Maciel, Laura Farrelly, Chel Hun Choi, Regina Berger, Christine Lee, Christof Vulsteke, Kosei Hasegawa, Elena Ioanna Braicu, Xiaohua Wu, Jodi McKenzie, John J Lee, Vicky Makker

10.1136/ijgc-2021-003017

November 19, 2021

PROPER—PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial

Andre Lopes, Alayne Magalhães Trindade Domingues Yamada, Thais de Campos Cardenas, Jaqueline Nunes de Carvalho, Emília de Azevedo Oliveira, Marina Elisa Ribeiro da Silva, Juliana Fenerich Mauri Andrade, Eduardo de Souza Neto, Lilian Arruda do Rêgo Barros, Ronaldo Lúcio Rangel Costa

10.1136/ijgc-2021-003170

November 8, 2021

A phase III randomized clinical trial comparing sentinel node biopsy with no retroperitoneal node dissection in apparent early-stage endometrial cancer – ENDO-3: ANZGOG trial 1911/2020

Andreas Obermair, Jim Nicklin, Val Gebski, Sandra C Hayes, Nicholas Graves, Linda Mileshkin, Ming Yin Lin, Phillip Beale, Eva Baxter, Kristy Robledo, Carlos Salomon, George B Hanna, Monika Janda

10.1136/ijgc-2021-003029

November 2, 2021

ADAGIO: a phase IIb international study of the Wee1 inhibitor adavosertib in women with recurrent or persistent uterine serous carcinoma

Joyce Liu, Amit M Oza, Nicoletta Colombo, Ana Oaknin

10.1136/ijgc-2021-003144

October 29, 2021

Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician’s choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

Lucia Musacchio, Vanda Salutari, Sandro Pignata, Elena Braicu, David Cibula, Nicoletta Colombo, Jean Sebastien Frenel, Flora Zagouri, Vittoria Carbone, Viola Ghizzoni, Serena Giolitto, Elena Giudice, Maria Teresa Perri, Caterina Ricci, Giovanni Scambia, Domenica Lorusso

10.1136/ijgc-2021-002593

October 4, 2021

ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA–MONO) and rucaparib in combination with nivolumab (ATHENA–COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer

Bradley J Monk, Robert L Coleman, Keiichi Fujiwara, Michelle K Wilson, Amit M Oza, Ana Oaknin, David M O’Malley, Domenica Lorusso, Shannon N Westin, Tamar Safra, Thomas J Herzog, Frederik Marmé, Ramez N Eskander, Kevin K Lin, Danny Shih, Sandra Goble, Nikolay Grechko, Stephanie Hume, Lara Maloney, Iain A McNeish, Rebecca S Kristeleit

10.1136/ijgc-2021-002933

September 30, 2021

BIOPSAR study: ultrasound-guided pre-operative biopsy to assess histology of sarcoma-suspicious uterine tumors: a new study protocol

Stamatios Petousis, Sabrina Croce, Michel Kind, Chrysoula Margioula-Siarkou, Guillame Babin, Caroline Lalet, Dennis Querleu, Anne Floquet, Marina Pulido, Frederic Guyon

10.1136/ijgc-2021-002995

September 29, 2021

Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer

Paul A Cohen, Penelope M Webb, Madeleine King, Andreas Obermair, Val Gebski, Phyllis Butow, Rachael Morton, Wanda Lawson, Patsy Yates, Rachel Campbell, Tarek Meniawy, Michelle McMullen, Andrew Dean, Jeffrey Goh, Orla McNally, Linda Mileshkin, Philip Beale, Rhonda Beach, Jane Hill, Cyril Dixon, Sue Hegarty, Jim Codde, Angela Ives, Yeh Chen Lee, Alison Brand, Anne Mellon, Sanela Bilic, Isobel Black, Stephanie Jeffares, Michael Friedlander

10.1136/ijgc-2021-002999

September 22, 2021

ATARI trial: ATR inhibitor in combination with olaparib in gynecological cancers with ARID1A loss or no loss (ENGOT/GYN1/NCRI)

Susana Banerjee, James Stewart, Nuria Porta, Christy Toms, Alexandra Leary, Stephanie Lheureux, Saira Khalique, Jeremy Tai, Ayoma Attygalle, Katherine Vroobel, Christopher J Lord, Rachael Natrajan, Judith Bliss

10.1136/ijgc-2021-002973

September 13, 2021

Determining post-operative morbidity and mortality following gynecological oncology surgery: protocol for a multicenter, international, prospective cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative—GO SOAR)

Faiza Gaba, Nicolò Bizzarri, Paul Kamfwa, Allison Saiz, Oleg Blyuss, Shantini Paranjothy, Pedro T Ramirez, David Cibula, on behalf of the GO SOAR Team, Mohamedraed Elshami, Mahmoud Saad, Ahmed Nafea, Muhammed Elhadi, Alaa Ismail, Hamza Al-Naggar, Darin Maria Cecilia, Maximilian Lanner, Andrei Pletnev, Basel Refky, Abdelazez Elkady, Tarek Karkour, Hazim Salah Ali, Sherief Ghozy, Sameh Daghash, Mohamed Hamed Elmelegy, Eman Monier, Mohammad Abdel-Rahman Mohammad, Domenico Ferraioli, Tanja Nikolova, Stamatios Petousis, Charalampos Theofanakis, Jagannth Mishra, Vadaparty Annapurna, Mariam Anjum Ifthikar, Anik Ghosh, Ajay Chanakya Vallabhaneni, Bijoy Kar, Alyaa Al-khafaji, Ali Al-Isawi, Michael O’Leary, Fabio Martinelli, Martina Arcieri, Stefano Restaino, Anna Fagotti, Edoardo Cola, Stefano Bogliolo, Qais Shatnawi, Aya Zazo, Amer Mahmoud Sindiani, Wafa Alsardieh, Abdulrahman Qasem, Shatha Husain, Maherah Kamarudin, Moniba Korch, Ishak Lawal, Adeyemi Okunowo, Mohammed Alkronz, Victor Lago, Amani Alsattari, Khalil Abuzaina, Farah Shahin, Ayat Aljuba, Waleed Abu Hatab, Najib Salameh, Adnan Radi, João Casanova, Kamil Zalewski, Amel Yousif, Igor Govorov, Ahmed Abu-Zaid, Susan Alghamdi, Antonio Gil Moreno, Natalia Rodriguez, Felix Boria, Zoia Razumova, Zuheir Alshehabi, Bassam Hassan, Hamdi Nawfal, Amr Hamza, Seda Şahin Aker, Salih Taskin, Ilker Kahramanoglu, Ilker Selcuk, Mahalakshmi Gurumurthy, Mary Cairns, Lori McPherson, Sadaf Ghaem-Maghami, John Butler, Christine Ang, Aarti Sharma, Hamza Al-Naggar, Sara Saif, Noor Abualdahab, Shohra Qaderi, Swali V Fundafunda, Mohammed Awad, Lina Karout, Mohamad B Kassab, Ali Safar, Reem Abdallah, Sana Hatoum, Said Mohamad Elmakkaoui, Rania Itani, Jihad El Hassan, Samar Karout, Hussein Mansour Jamal Edine, David Atallah, Salah Eddine Oussama Kacimi, Mustafa Mohamed, Chee Yang Tan, Hanan Haidar, Wafaa Shehada, Hisham Ahmed Abou-Taleb, Mohamed O. Herdan, Ali Hussien Ali, Ahmed Ragab Ali Ahmed, Omar Salah Ibrahim Mohamed, Mohamed I Omar, Eman Ibrahim Zineldin, Ahmed Sabry Fouad El-hamouly, Baraa N. Hajjaj, Shukri Odeh Yousef, Besan Shaheen, Akram Elhossini, Ziena Obiedat, Maen Alsumadi, Bisan Ahmed, Salsabeel Abed, Akram Husaini, Subhi Maher Abusharkh, Martina Aida Angeles

10.1136/ijgc-2021-002586

September 6, 2021