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

Phase 3

• Conditions: Cervical Cancer
• Interventions: Other: Neoadjuvant chemotherapy followed by surgery

• Registration Number: NCT01000415
• Lead Sponsor: Thai Gynecologic Oncology Collaborative Group

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Status Verified: 2010-03
• Last Update Submitted: 2010-06-23
• Last Update Posted: 2010-06-24
• Primary Completion: 2013-09
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 824

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin plus gemcitabine	Neoadjuvant chemotherapy followed by surgery	Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation

Primary Outcome Measures

Name	Time	Method
Overall survival comparison between experimental treatment group and standard treatment group	9 Years

Secondary Outcome Measures

Name	Time	Method
Comparing disease free survival between experimental treatment group and standard treatment group	9 years

Trial Locations

Locations (1)

Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University; 🇹🇭 Hat-Yai, Songkhla, Thailand