Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival comparison between experimental treatment group and standard treatment group
9 Years
Yes
Saibua B. Chichareon, MD.
Principal Investigator
Thai Gynecologic Oncology Collaborative Group (TGOC)
Thailand: Ethical Committee
TGOC-03
NCT01000415
June 2009
June 2018
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