Efficacy Study for Postoperative Chemoradiation Using Triweekly Cisplatin in Cervical Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Korea Cancer Center Hospital
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT00950261
First received: July 30, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cervical Neoplasms
Radiation: tri-weekly cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients

Resource links provided by NLM:


Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • disease-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • all kinds of toxicity [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tri-weekly cisplatin
Patients in this arm will postoperatively receive cisplatin 75mg/m2 intravenously every 3 weeks, 3 cycles with radiation
Radiation: tri-weekly cisplatin
cisplatin 75mg/m2 every 3 weeks, intravenous, 3 cycles

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950261

Contacts
Contact: Sang-Young Ryu, MD 82-8-970-1227 ryu@kcch.re.kr
Contact: Kidong Kim, MD 82-8-970-2297 kkd@kirams.re.kr

Locations
Korea, Republic of
Korea Institute of Radiological & Medical Sciences Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Sang-Young Ryu, MD    82-8-970-1227    ryu@kcch.re.kr   
Contact: Kidong Kim, MD    82-8-970-2297    kkd@kirams.re.kr   
Principal Investigator: Sang-Young Ryu, MD         
Sponsors and Collaborators
Korea Cancer Center Hospital
Investigators
Principal Investigator: Sang-Young Ryu, MD Korea Institute of Radiological & Medical Sciences
  More Information

No publications provided

Responsible Party: Sang-Young Ryu, Chair of Cerivcal/Ovarian Cancer Center, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00950261     History of Changes
Other Study ID Numbers: KCCH GY 1002
Study First Received: July 30, 2009
Last Updated: May 7, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea Cancer Center Hospital:
Cervical neoplasms
Cisplatin
Concurrent Chemoradiation

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014