A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00340184

Enrollment

Registered

2006-06-21

Start date

2004-08-31

Completion date

Unknown

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

concurrent, chemoradiation, paclitaxel, carboplatin

Brief summary

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical cancer patients.

Detailed description

Stage Ib to IIa cervical cancer can be treated effectively with either radioterapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors have been identified to compromise the treatment outcome. They include lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion. In these patients, postoperative RT is commonly recommended and has been demonstrated to improve the local control, but not survival rate. Recently, It is reported that the additon of concurrent chemotherapy to postoperative RT reduced pelvic failures and enhanced progression free survival. In addition, paclitaxel/platinum combination chemotherapy was demonstrated to have superior progression-free survical over single agent platinum in a primary treatment of stage IV or recurrent cervical cancer. Based on this obseration, we evaluated the efficacy and safety of CCRT with paclitaxel/carboplatin in patients with postoperative high risk factors.

Interventions

DRUGpaclitaxel, carboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Inclusion criteria

* Patients undertaken radical hysterectomy with diagnosis of invasive cervical cancer Ib-IIa (non-small cell type) * Patients must have at least one of the following risk factors; pelvic lymph node involvemet, involvement of vaginal resection margin,parametrial invasion. * Patients must have a GOG performance of 0, 1, or 2. * Patients must have expected life span over 6 months.

Exclusion criteria

* Patients with peripheral neurotoxicity over grade 2 in CTC criteria. * Patients with history of chemotherapy or radiation treatment. * Patients with histologicallly proven or highly suspected metastasis to paraaortic lymph node. * Patients with history of hypersensitive reaction to platinum agent.

Design outcomes

Primary

Measure	Time frame
Two year disease free survival	—

Secondary

Measure	Time frame
5 year overall survical, toxicity profile	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026