Phase III randomized trial of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy (RH) versus RH for bulky stage I/II cervical cancer (JCOG 0102)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5013-5013 ◽  
Author(s):  
N. Katsumata ◽  
H. Yoshikawa ◽  
T. Hirakawa ◽  
T. Saito ◽  
K. Kuzuya ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Radical Hysterectomy ◽  
Performance Status ◽  
Locally Advanced ◽  
Myometrial Invasion ◽  
Stage I ◽  
Phase Iii ◽  
Rank Test

5013 Background: NAC may represent an alternative to conventional RH for locally advanced cervical cancer. We compared NAC followed by RH with RH for bulky stage I/II cervical cancer. Methods: Patients (pts) with stage IB2, IIA (> 4 cm), or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7mg day 1–5, vincristine 0.7mg/m2 day 5, mitomycin 7mg/m2 day 5 and cisplatin 14 mg/m2 day 1–5,) q21 days, 2 to 4 cycles followed by radical hysterectomy (NAC arm) or undergo RH (RH arm). Pts with positive surgical margins, metastatic nodes, infiltration to parametrium, and/or deep myometrial invasion received postoperative irradiation. Eligibility included preserved organ function, aged 20–70, and Performance Status 0 or 1. Primary endpoint was overall survival (OS) to be compared by log-rank test. Assuming 100 eligible pts in each arm, the study had 80% power to detect a 15% increase in 5-year survival at 0.05 one-sided alpha. Results: 134 pts (67 NAC, 67 RH) were randomized between 12/01 and 08/05. The first planned interim analysis was performed in July 2005 using data from 108 pts registered as of 11/04. Data and Safety Monitoring Committee recommended to terminate the study because overall survival in NAC arm was inferior to that in RH arm (HR 2.11, multiplicity adjusted 99% CI 0.34 to 13.2) and the predictive probability of significant superiority using Spiegelhalter’s method of NAC arm was extremely low (6.4%). No increase of operability and no decrease of surgery-related morbidity were observed in NAC arm. Response Rate of NAC was 61% (33 of 54) using RECIST criteria. One-year progression-free survival and overall survival, updated as of 05/05, were 69.9% and 91.8% (95% CI 84.1–99.6) in NAC arm and 78.6% and 95.4% (95% CI 89.1–100) in RH arm respectively. Conclusions: Neoadjuvant chemotherapy with BOMP regimen followed by radical hysterectomy did not demonstrate clinical benefit, and conventional radical hysterectomy still remains to be a standard treatment option for bulky stage I/II cervical cancer. [Table: see text]

scholarly journals Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Jing Li ◽  
Hua Liu ◽  
Ya Li ◽  
Jian Li ◽  
Lifei Shen ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Disease Free

Abstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a thrice-weekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT. Methods This is a prospective, randomized, open-labeled, multicentered phase III study. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB–IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the study arm, patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied. Discussion The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer. Trial registration Chinese Clinical Trial Registry ChiCTR1900025327. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326

scholarly journals Comparison of Outcomes and Side Effects for Neoadjuvant Chemotherapy with Weekly Cisplatin and Paclitaxel Followed by Chemoradiation versus Chemoradiation Alone in Stage IIB-IVA Cervical Cancer: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Jing Li ◽  
Rong Cai ◽  
Hua Liu ◽  
Lifei Shen ◽  
Wenqing Long ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Cervical Cancer ◽  
Cancer Trial ◽  
Locally Advanced Cervical Cancer

Abstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a triweekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety and efficacy of NACT with weekly TP followed by CCRT. Methods This is a prospective, randomized, open-labeled, multicentered Phase III study with a sample size of 300. Patients with IIB-IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. Study arm: patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). Control arm: patients will undergo CCRT treatment. The primary endpoints of the study are overall survival rate and disease-free response rate; the secondary endpoint is the response rate 3 months after treatment completion; the tertiary endpoints are grade 3–4 adverse effects and quality of life; and potential biomarkers for predicting treatment response will also be studied. Conclusions The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer. Trial Registration Chinese clinical trial registry, ChiCTR1900025327; http://www.chictr.org.cn. Registered 24 August 2019 - Retrospectively registered, medresman.org.cn/ChiCTR1900025326

A randomized phase III study of gemcitabine (G) versus GV1001 in sequential combination with G in patients with unresectable and metastatic pancreatic cancer (PC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4601-4601 ◽  
Author(s):  
T. Buanes ◽  
J. Maurel ◽  
W. Liauw ◽  
M. Hebbar ◽  
J. Nemunaitis
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Locally Advanced ◽  
Peptide Vaccine ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ecog Performance Status ◽  
Delayed Treatment ◽  
Sequential Combination ◽  
The Impact

4601 Background: A phase I/II study with GV1001, a telomerase peptide vaccine, showed a median overall survival (OS) of 8.6 months in non-resectable PC (Bernhardt SL et al, Br J Cancer. 2006;95:1474–1482). This phase III trial was conducted to determine the impact on overall survival of G monotherapy vs. GV1001 in sequential combination with G in unresectable and metastatic PC. Methods: Eligible patients (pts) had chemotherapy-naive, advanced PC and ECOG performance status 0–1. Pts were randomized 1:1 to receive arm A: G (1,000 mg/m2 30 min i.v.) weekly for 7 weeks (w), 1w off and then 3w during 4-weekly cycles, or arm B: GV1001 0.56 mg s.c. plus GM-CSF as immune adjuvant on days 1, 3, 5, 8, 15, 22, 36, then every 4 weeks. Patients who progressed clinically or radiologically during GV1001 continued on GV1001 and concomitant gemcitabine. CT scans were performed every 8 weeks. The primary end-point was OS. A sample size of 520 patients allowed the detection of a hazard ratio (HR) of 0.73 (B/A), with 2α = 0.05 and 90% power. Results: Between June 2006 and May 2008, 365 pts were enrolled (A / B; 182 / 183). The study was stopped prematurely due to a preliminary analysis with 178 events showing no survival benefit of GV1001. Pts were well balanced for baseline characteristics: male 59.3% / 62.8%; median age 61y / 61y; ECOG PS 0 34.3% / 36.7%; locally advanced 22.4% / 20.7%. As of August 2008, 238 pts (A / B : 114 / 124) had died. Median OS was 7.3 / 5.9 months (HR 0.8; 95% CI 0.6–1.0). Median progression-free survival (PFS) was 3.7 / 1.9 months (HR 0.5; 95%CI 0.4–0.7). Grade 3–4 AEs: gastrointestinal 6% / 8%, infection 5% / 5%, vascular disorders 2% / 3%, neutropenia 6% / 3%. Conclusions: GV1001 did not show efficacy in sequential combination with G in advanced PC. The advantage of G monotherapy over the sequential combination may be due to the delayed treatment with G in arm B. [Table: see text]

Neoadjuvant chemotherapy plus radical surgery followed by chemotherapy in locally advanced cervical cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5093-5093
Author(s):  
Roberto Angioli ◽  
Francesco Plotti ◽  
Corrado Terranova ◽  
Michela Angelucci ◽  
Irma Oronzi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Platinum Based Chemotherapy ◽  
Node Metastases

5093 Background: The aim of this study is to evaluate the efficacy, in terms of overall survival and progression free survival, and safety of adjuvant chemotherapy after neoadjuvant chemotherapy followed by radical surgery both in patients with and without node metastases. Methods: Between June 2000 to May 2007, all patients with diagnosis of locally advanced cervical cancer referred to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome were elegible for this protocol.All enrolled patients received 3 cycles of platinum-based chemotherapy every 3 weeks according to the scheme cisplatin 100 mg/mq and paclitaxel 175 mg/mq. After neoadjuvant chemotherapy all patients with stable or progression to treatment were excluded from the protocol, all other were submitted classical radical hysterectomy and bilateral systematic pelvic lymph node dissection, and after to adjuvant treatment with 6 cycles of platinum based chemotherapy with cisplatin 100 mg/mq and paclitaxel 175 mg/mq. Results: 110 patients with local advanced cervical cancer received the treatment with neoadjuvant chemotherapy followed by radical surgery and adjuvant chemotherapy.Our study focused on clinical and operative data , in terms of overall survival and disease free survival at 5 and 3 years. 5-year OS of our series was 78% at five years and 86% at 3-years, with encouraging results also in subgroup with and without node mestastases. Conclusions: The adjuvant chemotherapy regimen after neoadjuvant chemotherapy and radical surgery rappresents a valid treatment option for patients with locally advanced cervical cancer without lymph node involvement, both in terms of overall survival than in terms of disease-free interval, the results have also confirmed the validity of this approach in lymph node metastases, with a complication rate lower than the standard radio-chemotherapy regime.

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