Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

Health Science Center of Xi'an Jiaotong University

Status and phase: Unknown; Phase 2

Conditions: Cervical Cancer

Treatments: Radiation: irradiation; Drug: Cisplatin; Drug: liposome paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01594099

GCR-02

Details and patient eligibility

About

The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.

Full description

Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.

Enrollment: 45 estimated patients

Sex: Female

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven squamous carcinoma of cervix
2. FIGO stageⅡB and ⅢB
3. Over 65 years
4. Do not receive other treatment
5. Performance index ECOG grade 0 to 2
6. Normal ECG
7. Normal hematological parameters
8. Normal renal and liver function tests

Exclusion criteria

1. Concomitant disease which may adversely affect the outcome
2. Poor nutritional status
3. Medical or psychological condition precluding treatment
4. Previous treatment
5. Concurrent treatment for any cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Radiotherapy alone

Active Comparator group

Treatment:

Radiation: irradiation

Radiotherapy plus cisplatin

Experimental group

Treatment:

Drug: Cisplatin

Radiotherapy plus liposome paclitaxel

Experimental group

Treatment:

Drug: liposome paclitaxel