Know Cancer

forgot password

A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients

Phase 2
20 Years
75 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:


Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



Korea: Institutional Review Board

Study ID:

KCCH GY 1001



Start Date:

March 2006

Completion Date:

October 2014

Related Keywords:

  • Cervical Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms