Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Neoadjuvant chemotherapy followed by surgery
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
Hat-Yai, Songkhla, Thailand
Status: Recruiting
Contact: Rakchai - Buhachat, MD. - 66 74 451201 - brakchai@medicine.psu.ac.th
Start Date
June 2009
Completion Date
June 2018
Sponsors
Thai Gynecologic Oncology Collaborative Group
Source
Thai Gynecologic Oncology Collaborative Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page