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

Cervical Cancer Clinical Trial

— TGOCphaseIII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01000415
• Other study ID #: TGOC-03
• Secondary ID: ECPSU-522231012
• Status: Recruiting
• Phase: Phase 3
• First received: October 21, 2009
• Last updated: June 23, 2010
• Start date: June 2009
• Est. completion date: June 2018

Study information

• Verified date: March 2010
• Source: Thai Gynecologic Oncology Collaborative Group
• Contact: Saibua B. Chichareon, MD.
• Phone: 66 74 451201
• Email: saibua.c[@]psu.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Food and Drug Administration
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 824
• Est. completion date: June 2018
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Neoadjuvant chemotherapy followed by surgery
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.

Locations

Country	Name	City	State
Thailand	Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University	Hat-Yai	Songkhla

Sponsors (3)

Lead Sponsor	Collaborator
Thai Gynecologic Oncology Collaborative Group	Clinical Research Collaborative Network, National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival comparison between experimental treatment group and standard treatment group		9 Years	Yes
Secondary	Comparing disease free survival between experimental treatment group and standard treatment group		9 years	Yes