scholarly journals Adjuvant chemotherapy following definitive chemo radiation in patients with locally advanced cervical cancer: A phase II clinical trial

2017 ◽  
Vol 28 ◽  
pp. x90
Author(s):  
F. Amouzegar Hashemi
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Locally Advanced ◽  
Phase Ii Clinical Trial ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer

Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation Versus Chemoradiation for Locally Advanced Cervical Cancer: A Randomized Phase II Trial

2019 ◽  
Vol 37 (33) ◽  
pp. 3124-3131 ◽  
Author(s):  
Samantha Cabral S. da Costa ◽  
Renata Colombo Bonadio ◽  
Flavia Carolina G. Gabrielli ◽  
Andrea S. Aranha ◽  
Maria Luiza N. Dias Genta ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Additional Treatment ◽  
Hazard Ratio ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Gynecology And Obstetrics

PURPOSE Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Additional treatment strategies are required to improve outcomes. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by CRT. METHODS In this phase II trial, patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) were randomly assigned to three cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life. RESULTS From 107 patients enrolled in the trial, 55 were randomly assigned to the NAC arm and 52 to the CRT-alone arm. The majority of patients had squamous cell carcinoma (87.8%). After a median follow-up of 31.7 months, NAC was associated with an inferior PFS, with 3-year PFS rates of 40.9% v 60.4% in the CRT arm (hazard ratio, 1.84; 95% CI, 1.04 to 3.26; P = .033). NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006). After treatment completion, complete response rates were 56.3% in the NAC arm and 80.3% in the CRT arm ( P = .008). Toxicities were similar in both arms, with the exception of hypomagnesemia and neuropathy being more common with NAC. CONCLUSION This study shows that the addition of NAC consisting of cisplatin and gemcitabine to standard CRT is not superior and is possibly inferior to CRT alone for the treatment of LACC.

A phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: The OUTBACK TRIAL.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS5116-TPS5116
Author(s):  
Linda R. Mileshkin ◽  
Kailash Narayan ◽  
Kathleen N. Moore ◽  
Danny Rischin ◽  
Edward Lloyd Trimble ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
New Zealand ◽  
Adjuvant Chemotherapy ◽  
Gynecologic Cancer ◽  
Locally Advanced ◽  
Primary Objective ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
The Usa

TPS5116 Background: Cervical cancer is a global health problem and the most common cause of cancer-related death among women in developing nations. Despite the recently developed cervical cancer vaccine, many women will continue to die from cervical cancer for many decades unless existing treatments can be improved. Unscreened women often present with locally-advanced disease that has a 5 year overall survival (OS) rate of 60% or less following standard chemo-radiation. Although some evidence suggests that adjuvant chemotherapy following chemo-radiation may be of value, its role remains controversial. Methods: OUTBACK is a randomized phase III Gynecologic Cancer InterGroup (GCIG) trial designed and led by the Australia New Zealand Gynaecological Oncology Group (ANZGOG) in collaboration with the NHMRC Clinical Trials Centre. Participating countries (groups) include Australia and New Zealand (ANZGOG), India, the USA and Canada (GOG, RTOG). OUTBACK is suitable for women with locally advanced cervical cancer (FIGO stage IB1 and node positive, IB2, II, IIIB or IVA). The primary objective is to determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemo-radiation improves OS. Women are randomized to either A) standard cisplatin-based chemo-radiation or B) standard cisplatin-based chemo-radiation followed by 4 cycles of carboplatin and paclitaxel chemotherapy. Secondary objectives are to compare progression-free survival, treatment-related toxicity, patterns of disease recurrence, quality of life and psycho-sexual health, and the association between radiation protocol compliance and outcomes. Blood and tumour samples are collected from consenting patients for future translational studies. 780 women will be enrolled to determine if the addition of adjuvant chemotherapy can improve the 5-year OS rate by ≥ 10%. OUTBACK opened in Australia and New Zealand in 2011. In early 2012 the trial opened in the USA and activation of GOG sites is ongoing. 15 patients have been randomized. It is expected that RTOG and India will open the trial later this year with recruitment increasing substantially once all sites are activated.

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