Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Cancer Center Hospital
• Treatments: Cisplatin

Criteria

Inclusion criteria:

1. Histologically confirmed cervical cancer

2. Clinical stage from 2b to 4a

3. Equal to or younger than 75

4. Gog performance status 0 - 2

5. Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl

6. Serum creatinine < 2.0

7. AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl

8. Expected survival equal to or longer than 6 months

9. Who agreed to participate in this study

Exclusion criteria:

1. History of chemotherapy or radiation to abdomen or pelvis

2. History of other cancers

3. Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2

4. History of allergy or hypersensitivity reaction to platinum

5. History of atrial or ventricular arrhythmia, or congestive heart failure

6. Uncontrolled diabetes, hypertension, or ischemic heart disease

7. Myocardial infarction within 6 months

8. Sepsis or severe infection

9. Pregnant women

10. An unapproved therapy within 30 days before enrollment

11. Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial