Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
Summary
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.
However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.
Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.
Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.
We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).
Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.
Description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in early-stage disease. However, advanced disease carries a poor prognosis.
Current standard treatment for locally advanced cervical cancer, which is not eligible for surgical treatment, is cisplatin-based concurrent chemoradiation. On the basis of the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based chemoradiation, the U.S. National Cancer Institute (NCI) announced in 1992 that "Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with radiotherapy in women who require radiotherapy for treatment of cervical cancer".
Although recently reported meta-analyses also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent with radiation, the optimal cisplatin dose and dosing schedule are still undetermined.
Among the previous five randomized clinical trials, two trials performed by the Gynecologic Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil (5-FU). Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU combined regimens.
However weekly cisplatin regimen needs frequent hospital visits and had a poor compliance profile in korea. With weekly cisplatin regimen, planned treatment was not completed in 58% patients adn treatment delayed in 29% patient. among these patients, 9% patients were not related associated toxicities.
To overcome toxicities and poor compliance of weekly regimen, the investigators tried to evaluate the efficacy and feasibility of CCRT with cisplatin 75mg/m2 every 3 weeks.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
CERVICAL NEOPLASMS
Intervention
CONCURRENT CHEMORADIATION (CISPLATIN)
Location
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul
Korea, Republic of
139-706
Status
Active, not recruiting
Source
Korea Cancer Center Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00916500
- Information obtained from ClinicalTrials.gov on April 25, 2012
Medical and Biotech [MESH] Definitions
Cisplatin
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
Cervical Plexus
A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.
Cervical Length Measurement
A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.
Neoplasms By Site
A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.
Uterine Cervical Neoplasms
Tumors or cancer of the UTERINE CERVIX.
Clinical Trials
The standard postoperative treatment for patients with cervical cancer who had high-risk factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have been used...
Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally...
Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer
The current standard for locally advanced cervical cancer is concurrent cisplatin-based chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play an imp...
The purpose of this study is: - to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surger...
This phase III study is designed to examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based chemoradiation...
PubMed Articles
ABSTRACT: Purpose/Objective: This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Ma...
Concurrent chemoradiation for adenoid cystic carcinoma of the head and neck.
BACKGROUND: We performed a retrospective review of patients with nonresected head and neck adenoid cystic carcinoma (ACC) treated with concurrent chemoradiation. METHODS: Sixteen patients (nasopharynx...
Current Management of Cervical Esophageal Cancer.
BACKGROUND: Pharyngo-laryngo-esophagectomy (PLE) has been regarded as a standard treatment for cervical esophageal cancer, but the morbidity and mortality rates associated with PLE are substantial. Ch...
BACKGROUND: Intensification of chemoradiation for advanced head and neck squamous cell carcinoma (HNSCC) is unlikely due to toxicity. Cetuximab combined either with radiotherapy or with chemotherapy s...
Background: The London Regional Cancer Program (LRCP) uses a unique schedule of induction plus concurrent chemoradiation, termed VCRT (vinblastine, cisplatin, and radiation therapy), for the treatment...
