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

Cervical Cancer Clinical Trial

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

Clinical Trial Summary

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)

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01000415
Study type Interventional
Source Thai Gynecologic Oncology Collaborative Group
Contact Saibua B. Chichareon, MD.
Phone 66 74 451201
Email saibua.c@psu.ac.th
Status Recruiting
Phase Phase 3
Start date June 2009
Completion date June 2018
View Details
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