A Phase II Trial with Cisplatin-Paclitaxel Cytotoxic Treatment and Concurrent External and Endocavitary Radiation Therapy in Locally Advanced or Recurrent Cervical Cancer

Oncology ◽  
2006 ◽  
Vol 70 (1) ◽  
pp. 19-24 ◽  
Author(s):  
L. Miglietta ◽  
P. Franzone ◽  
M.G. Centurioni ◽  
L. Boni ◽  
L. Tacchini ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Recurrent Cervical Cancer ◽  
Cytotoxic Treatment

scholarly journals PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System

Cancers ◽  
2021 ◽  
Vol 13 (20) ◽  
pp. 5179
Author(s):  
Anouk Corbeau ◽  
Remi A. Nout ◽  
Jan Willem M. Mens ◽  
Nanda Horeweg ◽  
Jérémy Godart ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Proton Therapy ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
External Beam Radiation ◽  
Beam Radiation ◽  
Intensity Modulated ◽  
The Impact

External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a very effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient’s quality of life (QoL) and ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). However, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy. Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC.

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.

Trial in progress: Phase II study of stereotactic body radiation therapy and atezolizumab in the management of recurrent, persistent, or metastatic cervical cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5596-TPS5596
Author(s):  
Kamran A. Ahmed ◽  
Youngchul Kim ◽  
Sachin M. Apte ◽  
Hye Sook Chon ◽  
Jing-Yi Chern ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Stereotactic Body Radiation Therapy ◽  
Objective Response ◽  
Primary Objective ◽  
Open Label ◽  
Recurrent Cervical Cancer ◽  
Stereotactic Body Radiation ◽  
Hypofractionated Radiation

TPS5596 Background: There is no consistent recommendation for management of metastatic cervical cancer beyond first line therapy with chemotherapy and bevacizumab. Pembrolizumab is now approved for PD-L1 positive or MSI-H/dMMR metastatic or recurrent cervical cancer. Numerous pre-clinical studies have provided evidence to combine radiation therapy with immune checkpoint inhibition to improve response rates. The evidence is strongest for short course, hypofractionated radiation regimens. We hypothesize treatment with atezolizumab with hypofractionated radiation therapy will improve objective response rate (ORR) compared with atezolizumab alone in patients with recurrent, persistent, or metastatic cervical cancer. Methods: The study is designed as a prospective, single arm, nonrandomized, open-label, phase II trial of stereotactic body radiation therapy (SBRT) with 24 Gy in 3 fractions to patients with ≥ 2 metastatic sites followed 1 week later by atezolizumab (1200 mg IV every 3 weeks) for patients with recurrent, persistent, or metastatic cervical cancer. Dose reductions will not be allowed. The primary objective of the study is to evaluate the ORR by Immune-Modified Response Evaluation Criteria in Solid Tumors (irRECIST) criteria following SBRT and atezolizumab. Secondary endpoints include progression free survival, overall survival, local control, and adverse events. Correlative aims include assessing blood and tissue biomarkers (i.e. PD-L1, mutation burden, TCR repertoire etc.) for association with clinical benefit. A total of 26 patients will be enrolled. An interim analysis will be performed to assess efficacy after 13 patients become evaluable.This study is open with 2 patients enrolled at the time of submission. Clinical trial information: NCT03614949.

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