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Trial Title:
Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
NCT ID:
NCT01000415
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Neoadjuvant chemotherapy followed by surgery
Description:
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.
Arm group label:
Cisplatin plus gemcitabine
Other name:
Platinol,Platinol-AQ
Other name:
Gemzar
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
Address:
City:
Hat-Yai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Rakchai - Buhachat, MD.
Phone:
66 74 451201
Email:
brakchai@medicine.psu.ac.th
Contact backup:
Last name:
Chutaporn - Dampan, BSc.
Phone:
66 74 451201
Email:
djutapor@medicine.psu.ac.th
Investigator:
Last name:
Rakchai - Buhachat, MD.
Email:
Principal Investigator
Start date:
June 2009
Completion date:
June 2018
Lead sponsor:
Agency:
Thai Gynecologic Oncology Collaborative Group
Agency class:
Other
Collaborator:
Agency:
National Research Council of Thailand
Agency class:
Other
Collaborator:
Agency:
Clinical Research Collaborative Network
Agency class:
Other
Source:
Thai Gynecologic Oncology Collaborative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01000415
