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A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)


Phase 3
20 Years
75 Years
Open (Enrolling)
Female
Uterine Cervical Neoplasms

Thank you

Trial Information

A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)


Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable
to curative treatment with surgery and/or radiation therapy, still remains poor. Recently,
cisplatin plus paclitaxel for palliative chemotherapy were reported to improve the response
rate and progression-free interval compared to cisplatin alone and has been shown as a new
appropriate regimen. However, more effective and/or less toxic combinations are needed.
Carboplatin as a single agent has less response rate but less overall toxicity than
cisplatin. Particularly, because less nephrotoxicity does not require hydration and less
neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient
therapy becomes possible and patients' quality of life must improve. Therefore, we planned
to evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and
carboplatin, which could reduce the hospitalised days, in comparison with the standard
chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the
patients in Japan with incurable cervical cancer diagnosed by means of image.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

During the study conduct

Safety Issue:

No

Principal Investigator

Toshiharu Kamura, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Kurume University School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0505

NCT ID:

NCT00295789

Start Date:

February 2006

Completion Date:

November 2011

Related Keywords:

  • Uterine Cervical Neoplasms
  • cervical cancer
  • palliative chemotherapy
  • recurrent
  • persistent
  • stageⅣb
  • cisplatin
  • carboplatin
  • paclitaxel
  • Neoplasms
  • Uterine Cervical Neoplasms

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