Overview

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