Clinical trial NCT00950261: Efficacy Study for Postoperative Chemoradiation Using Triweekly Cisplatin in Cervical Cancer Patients
Official title: Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cervical Neoplasms
Keywords: Cervical neoplasms
Cisplatin
Concurrent Chemoradiation
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 as chemotherapy regimens of chemoradiation. Based on their experience, the investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin. Therefore, the investigators are going to perform the efficacy study of postoperative, tri-weekly cisplatin chemoradiation for patients with cervical cancer.

Detailed description: Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with around 80-90% 5-year survival rate in early stage disease. However, advanced disease carries a poor prognosis.

The standard postoperative treatment for patients with cervical cancer who had high-risk factors is chemoradiation. Based on the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based CRT, the National Cancer Institute (NCI) of the United States announced that 'Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with RT in women who require radiation therapy for treatment of cervical cancer' in 1999.

Although recently reported meta-analysis studies also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT), 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, as a result of the GOG 165 study, which was closed prematurely because an interim analysis found that patients in the 5-FU treatment group were not likely to achieve a better outcome, the role of 5-FU (previously popularly included in clinical trials) as a radiosensitizer became subject to debate. Furthermore, a clinical trial performed by the NCI in Canada comparing pelvic RT alone with weekly cisplatin 40 mg/m2 concurrent to RT failed to show improvement of progression free and 5-year survival. While the authors suggested several possible reasons for why their study failed to demonstrate a survival benefit with concurrent weekly cisplatin 40 mg/m2 chemotherapy, other investigators have tried to find another optimal dose and dosing schedule for cisplatin administration.

In light of the results of the previous clinical trial that indicated 5-FU may not be an active radiosensitizer, weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 remain the most popular cisplatin doses and dosing schedules. However, despite the possible advantages of tri-weekly cisplatin 75 mg/m2, which offer an increased peak concentration of cisplatin and cisplatin administration during brachytherapy, no clinical trials have efficacy of tri-weekly cisplatin-based chemotherapy concurrent to RT.

Therefore, the investigators are going to perform the efficacy study of postoperative, tri-weekly cisplatin chemoradiation for patients with cervical cancer.

Eligibility criteria: Inclusion Criteria:

* cervical cancer
* underwent radical hysterectomy
* non-small cell type
* FIGO stage 1B - 2A
* have one or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
* GOG performance status 0 - 2

Exclusion Criteria:

* Previous history of chemotherapy or radiation
* History of other cancer
* Hypersensitivity to platinum agents
* Pregnancy
* Serious medical disease

Primary outcomes:
measure: disease-free survival
timeFrame: 2 year
Secondary outcomes:
measure: overall survival
timeFrame: 2 year
measure: disease-free survival
timeFrame: 5 year
measure: overall survival
timeFrame: 5 year
measure: all kinds of toxicity
timeFrame: during treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Radiological & Medical Sciences
Study officials:
affiliation: Korea Institute of Radiological & Medical Sciences
name: Sang-Young Ryu, MD
role: PRINCIPAL_INVESTIGATOR
References: