Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer

NCT00916500 | Completed Phase 2

• 1 other identifier: KCCH GY 1001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CERVICAL NEOPLASMS

Keywords

CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN

Outcome Measures

Primary Outcomes (1)

• DISEASE-FREE SURVIVAL

  5 YEAR AFTER THERAPY

Secondary Outcomes (4)

• DISEASE-FREE SURVIVAL

  2 YEAR AFTER THERAPY

• OVERALL SURVIVAL

  FROM THERAPY TO DEATH

• RECURRENCE RATE

  2 YEAR AFTER THERAPY

• RECURRENCE RATE

  5 YEAR AFTER THERAPY

Study Arms (1)

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)

Interventions

CONCURRENT CHEMORADIATION (CISPLATIN) DRUG

Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A

Also known as: Cisplatin

CISPLATIN

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead

Study Sites (1)

Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Seoul, 139-706, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• SANG YOUNG RYU, M.D.

  STAFF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Cerivcal/Ovarian Cancer Center

Study Record Dates

• First Submitted: June 7, 2009
• First Posted: June 9, 2009
• Study Start: March 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

KR (1)