Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is: to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb) to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

Detailed Description
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According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

Official Title
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Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: Neoadjuvant chemotherapy followed by surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical cancer patients with FIGO stage Ib2-early IIb Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma ECOG performance status 0-1 No previous treatment for cervical cancer Acceptable hematological,renal,liver function Exclusion Criteria: Previous history of cancer Underlying disease not fit for surgery Psychological problem Obvious pelvic/para-aortic node involvement Pregnancy HIV positive History of bowel obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin plus gemcitabine<br>Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation | Other: Neoadjuvant chemotherapy followed by surgery<br>* Cisplatin 50 mg/m2 (in the vein)on day 1 of each 23 day cycle plus gemcitabine 1000 mg/m2 (in the vein) on day 1 and day 8, for 3 cycles: until progression or unacceptable toxicity develops.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival comparison between experimental treatment group and standard treatment group |  | 9 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing disease free survival between experimental treatment group and standard treatment group |  | 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage Ib2-early IIb of cervical cancer, Neoadjuvant chemotherapy, Cisplatin plus gemcitabine, Radical hysterectomy with pelvic lymphadenectomy, Quality of life, Stage Ib2-IIb of cervical cancer patients