Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

1. Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix

2. FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis

3. ECOG performance score 0-1

4. The bone marrow, hepatic and renal function was normal at registration

5. The patients signed informed consent

Exclusion Criteria:

1. clear cell and small cell neuroendocrine, sarcoma

2. FIGO stage IVB

3. Prior invasive malignancy

4. Prior systemic chemotherapy

5. Prior radiotherapy to the pelvis or abdomen

6. Severe, active co-morbidity

7. Women who are pregnant

8. immunocompromised status