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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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paclitaxel, carboplatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Soon Beom Kang, Professor

Role: STUDY_CHAIR

Korean Gynecologic Oncology Group

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee TS, Kang SB, Kim YT, Park BJ, Kim YM, Lee JM, Kim SM, Kim YT, Kim JH, Kim KT. Chemoradiation with paclitaxel and carboplatin in high-risk cervical cancer patients after radical hysterectomy: a Korean Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):304-10. doi: 10.1016/j.ijrobp.2013.01.035.

Reference Type DERIVED

PMID: 23642625 (View on PubMed)

Other Identifiers

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KGOG1001

Identifier Type: -

Identifier Source: org_study_id