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


Phase 2
20 Years
75 Years
Not Enrolling
Female
Cervical Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two year disease free survival

Principal Investigator

Soon Beom Kang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Korean Gynecologic Oncology Group

Authority:

Korea: Food and Drug Administration

Study ID:

KGOG1001

NCT ID:

NCT00340184

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Cervical Cancer
  • concurrent
  • chemoradiation
  • paclitaxel
  • carboplatin
  • Uterine Cervical Neoplasms

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