Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00842660
• Other study ID #: 97-1165A3
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 8, 2009
• Last updated: January 3, 2010
• Start date: February 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2009
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.

Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.

Description:

I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.

Secondary end points:

1. Acute toxicity during treatment

2. Tumor response rates

3. Sites of recurrence

4. Long-term complications and quality of life II). Design of study

An open-label, prospective randomized trial with two treatment arms:

• Arm I: Patients receive CCRT with weekly cisplatin only.

• Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.

Conduct of study

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 172
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed primary squamous cell carcinoma of the uterine cervix.

• Previously untreated disease.

• Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.

• No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.

• Ages eligible: 35 years - 70 years.

• Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg% (creatinine clearance > 60 ml/min).

• Performance status 0 or 1 (see Appendix I).

• The interval between RT and randomization is not greater than 3 weeks.

• Patients must have signed informed consent to participate this study.

Exclusion Criteria:

• Age > 70 or < 35

• Medical or psychological condition that would preclude treatment.

• Previous chemotherapy or pelvic RT.

• Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.

• Patient unreliable for treatment completion and follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride

Locations

Country	Name	City	State
Taiwan	Chong Jong Wang,	Kaohsiung
Taiwan	Chien-Sheng Tsai	Keelung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Eli Lilly and Company

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival, including overall survival and progression-free survival.		2012,	Yes
Secondary	1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life		2013	Yes