Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer - Full Text View

Sponsor:	Korea Cancer Center Hospital
Information provided by:	Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:	NCT00916500

Purpose

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	Intervention	Phase
Cervical Neoplasms	Drug: CONCURRENT CHEMORADIATION (CISPLATIN)	Phase II

Study Type:	Interventional
Study Design:	Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:

DISEASE-FREE SURVIVAL [ Time Frame: 5 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DISEASE-FREE SURVIVAL [ Time Frame: 2 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]
OVERALL SURVIVAL [ Time Frame: FROM THERAPY TO DEATH ] [ Designated as safety issue: No ]
RECURRENCE RATE [ Time Frame: 2 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]
RECURRENCE RATE [ Time Frame: 5 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CISPLATIN: Experimental 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

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Histologically confirmed cervical cancer
Clinical stage from 2b to 4a
Equal to or younger than 75
Gog performance status 0 - 2
Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl
Serum creatinine < 2.0
AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl
Expected survival equal to or longer than 6 months
Who agreed to participate in this study

Exclusion criteria:

History of chemotherapy or radiation to abdomen or pelvis
History of other cancers
Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2
History of allergy or hypersensitivity reaction to platinum
History of atrial or ventricular arrhythmia, or congestive heart failure
Uncontrolled diabetes, hypertension, or ischemic heart disease
Myocardial infarction within 6 months
Sepsis or severe infection
Pregnant women
An unapproved therapy within 30 days before enrollment
Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916500

Locations

Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, Korea, Republic of, 139-706

Sponsors and Collaborators

Korea Cancer Center Hospital

Investigators

Principal Investigator:

SANG YOUNG RYU, M.D.

STAFF

More Information

No publications provided

Responsible Party:	KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES ( SANG YOUNG RYU/STAFF, DEPARTMENT OF OB&GY )
ClinicalTrials.gov Identifier:	NCT00916500 History of Changes
Other Study ID Numbers:	KCCH GY 1001
Study First Received:	June 7, 2009
Last Updated:	August 27, 2010
Health Authority:	KOREA: KIRAMS IRB

Keywords provided by Korea Cancer Center Hospital:

CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN

Additional relevant MeSH terms:

Neoplasms

Uterine Cervical 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

Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 06, 2010