Clinical trial NCT01594099: Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women
Official title: Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervical cancer
elderly women
concurrent chemotherapy
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 1 month after the treatment completed
measure: Adverse Events
timeFrame: Participants will be followed from the treatment begin to 1 month after the treatment end.
Secondary outcomes:
measure: Local Control Rate
timeFrame: Participants will be followed every year for the duration of 5 years
measure: Tumor Free Survival Rate
timeFrame: From date of randomization until tumor recurrence or metastasis,assessed up to 5 years
measure: Overall Survival Rate
timeFrame: From date of randomization until the date of death from any cause,assessed up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Medical College of Xi'an Jiaotong University
name: Chen M W, M.D
role: STUDY_DIRECTOR
References: