Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. histologically proven uterine cervical cancer

2. squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix

3. one of the followings, 1)primary stage Ⅳb cervical cancer, 2)the first relapse or persistent cervical cancer after curative first line treatments, 3)the second relapse or persistent cervical cancer after curative second line treatments including radiation, systemic chemotherapy, hormonal therapy, or vaccination therapy for the first relapse

4. Patients may have been previously treated with less than 50 Gy of palliative radiation therapy

5. Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiation therapy

6. one of the followings, 1)There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN, 2)There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and some of the lesions have been irradiated, 3)All lesions are localized inside the pelvic cavity, and some of them have been irradiated

7. no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity

8. no bilateral hydronephrosis

9. no prior chemotherapy including more than two platinum-containing regimens

10. no prior chemotherapy including taxane

11. age: 20 to75 years

12. PS: 0-2

13. ANC ≧1,500 /mm3, Plt≧10.0×104/mm3, T-bil≦1.5 mg/dl, GOT（AST）≦100IU/l, sCre ≦1.2 mg/dl, Ccr≧50ml/min in using the Cockcroft-Gault equation, and normal ECG

14. written informed consent

Exclusion Criteria:

1. patients who have some neurologically functional disorder

2. symptomatic CNS metastasis

3. hypersensitive to alcohol

4. active infection

5. HBs antigen positive

6. uncontrollable hypertension

7. history of myocardiac infarction within six months

8. unstable angina

9. uncontrollable diabetes

10. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years

11. women during pregnancy or breast-feeding

12. patients with psychiatric illness

13. patients who have been treated with the systemic steroids medication