Clinical trial NCT01000415: Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
Official title: Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: 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
Lead sponsor: Thai Gynecologic Oncology Collaborative Group
Sponsor class: NETWORK
Collaborators: name: National Research Council of Thailand
name: Clinical Research Collaborative Network
First posted: 2009-10-23
Enrollment: 824
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival comparison between experimental treatment group and standard treatment group
timeFrame: 9 Years
Secondary outcomes:
measure: Comparing disease free survival between experimental treatment group and standard treatment group
timeFrame: 9 years
Other outcomes:
Locations:
city: Hat-Yai
country: Thailand
facility: Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Thai Gynecologic Oncology Collaborative Group (TGOC)
name: Saibua B. Chichareon, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Termrungruanglert W, Tresukosol D, Vasuratna A, Sittisomwong T, Lertkhachonsuk R, Sirisabya N. Neoadjuvant gemcitabine and cisplatin followed by radical surgery in (bulky) squamous cell carcinoma of cervix stage IB2. Gynecol Oncol. 2005 May;97(2):576-81. doi: 10.1016/j.ygyno.2005.01.048.