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Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy


Phase 3
18 Years
75 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy


Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage
cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy
plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph
node metastasis, the involvement of vaginal resection margin, and the parametrial invasion,
have been identified to compromise the patient prognosis.

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment
for patients with cervical cancer. However, many patients with pathological risk factors
treated with concurrent radiotherapy plus single agent cisplatin still suffered from the
local or distant relapse. How to improve the treatment outcome of these patients is a very
important issue and requires further clinical investigation.

Paclitaxel has been demonstrated to be a good radiosensitizer. In addition,
paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior
progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is
not yet known whether chemotherapy and radiation therapy are more effective when given with
consolidation chemotherapy in treating cervical cancer.

Therefore, the investigators are going to perform the efficacy and safety study of
postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with
consolidation chemotherapy in high-risk patients with early-stage cervical cancer following
radical hysterectomy.


Inclusion Criteria:



- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b
(non-small cell type)

- One or more risk factors (lymph node involvement, resection margin involvement,
parametrial involvement)

- Eastern Cooperative Oncology Group 0-2

- Expected life span over 6 months.

- No distant metastasis

- Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥
100,000/ul, haemoglobin≥ 10g/dl)

- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

- Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate
aminotransferase/alanine aminotransferase ≤ 3 times(normal value)

- Written informed consent

Exclusion Criteria:

- Previous history of chemotherapy or radiation

- Hypersensitive reaction to platinum/paclitaxel agent

- History of other cancer

- Concurrent systemic illness not appropriate for chemotherapy

- Active infection requiring antibiotics

- Pregnancy

- Metastasis to paraaortic lymph node

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

WZMC-11256

NCT ID:

NCT01755845

Start Date:

January 2011

Completion Date:

December 2016

Related Keywords:

  • Cervical Cancer
  • cervical cancer
  • radiotherapy
  • postoperative therapy
  • chemotherapy
  • Uterine Cervical Neoplasms

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