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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: concurrent chemotherapy with docetaxel; Drug: adjuvant chemotherapy with cisplatin and docetaxel; Radiation: pelvic radiotherapy; Radiation: brachytherapy; Drug: concurrent chemotherapy with cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02703961

XJFL-2016-02-LACC-TP triweekly

Details and patient eligibility

About

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.

Full description

The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.

Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.

The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.

Enrollment: 598 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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598 participants in 2 patient groups

experimental

Experimental group

Description:

concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy. During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22. After external beam radiotherapy: cisplatin 75mg/m2, d43,d64; The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. docetaxel 75mg/m2, d43,d64.

Treatment:

Drug: concurrent chemotherapy with cisplatin

Radiation: brachytherapy

Radiation: pelvic radiotherapy

Drug: adjuvant chemotherapy with cisplatin and docetaxel

Drug: concurrent chemotherapy with docetaxel

control

Other group

Description:

standard chemoradiotherapy with weekly cisplatin. Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

Treatment:

Drug: concurrent chemotherapy with cisplatin

Radiation: brachytherapy

Radiation: pelvic radiotherapy