Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
|ClinicalTrials.gov Identifier: NCT00916500|
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : May 1, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|CERVICAL NEOPLASMS||Drug: CONCURRENT CHEMORADIATION (CISPLATIN)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Patients With Locally Advanced Cervical Cancer Who Underwent Concurrent Chemoradiation; Cisplatin 75mg/m2 IV Every 3 Week For 3 Cycles; External Pelvic Radiation 40 Gy; Brachytherapy Up to 85-90 Gy To Point A
Drug: CONCURRENT CHEMORADIATION (CISPLATIN)
Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
Other Name: Cisplatin
- DISEASE-FREE SURVIVAL [ Time Frame: 5 YEAR AFTER THERAPY ]
- DISEASE-FREE SURVIVAL [ Time Frame: 2 YEAR AFTER THERAPY ]
- OVERALL SURVIVAL [ Time Frame: FROM THERAPY TO DEATH ]
- RECURRENCE RATE [ Time Frame: 2 YEAR AFTER THERAPY ]
- RECURRENCE RATE [ Time Frame: 5 YEAR AFTER THERAPY ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916500
|Korea, Republic of|
|Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences|
|Seoul, Korea, Republic of, 139-706|
|Principal Investigator:||SANG YOUNG RYU, M.D.||STAFF|