Cervical CancerPhase 3TGOCphaseIIINCT01000415
Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
A Phase 3 study testing Neoadjuvant chemotherapy followed by surgery in people with Cervical Cancer, run by Thai Gynecologic Oncology Collaborative Group at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Neoadjuvant chemotherapy followed by surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Rakchai - Buhachat, MD., 66 74 451201, brakchai@medicine.psu.ac.th
Chutaporn - Dampan, BSc., 66 74 451201, djutapor@medicine.psu.ac.th
About this study
Official title: Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma
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)
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Neoadjuvant chemotherapy followed by surgery
- 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
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy followed by surgeryOther
Also called Platinol,Platinol-AQ, Gemzar
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.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin plus gemcitabine | Experimental | Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation Receives: Other: Neoadjuvant chemotherapy followed by surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival comparison between experimental treatment group and standard treatment group
Measured: 9 Years
Secondary outcomes (1)
Comparing disease free survival between experimental treatment group and standard treatment group
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2013 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thai Gynecologic Oncology Collaborative Group
- Sponsor type
- Research network
- Collaborators
- National Research Council of Thailand, Clinical Research Collaborative Network
- Investigators
- Saibua B. Chichareon, MD., Principal investigator, Thai Gynecologic Oncology Collaborative Group (TGOC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000415
- Sponsor's protocol ID
- TGOC-03
- Other IDs
- ECPSU-522231012
- Acronym
- TGOCphaseIII
- Status last verified
- Mar 2010
- First submitted
- 21 Oct 2009
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15863162
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT01000415
- Acronym / sponsor ID
- TGOCphaseIII / TGOC-03
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 824 participants (estimated)
- Lead sponsor
- Thai Gynecologic Oncology Collaborative GroupResearch network
- Collaborators
- National Research Council of Thailand, Clinical Research Collaborative Network
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin plus gemcitabine | Experimental | Other: Neoadjuvant chemotherapy followed by surgeryExperimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Previous history of cancer
- Underlying disease not fit for surgery
- Psychological problem
- Obvious pelvic/para-aortic node involvement
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapy followed by surgeryAlso: Platinol,Platinol-AQ, GemzarCisplatin 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. | Other | Cisplatin plus gemcitabine |
Primary outcome
Overall survival comparison between experimental treatment group and standard treatment group
Time frame: 9 Years
1 secondary outcome
Comparing disease free survival between experimental treatment group and standard treatment group
Time frame: 9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
- Background: PubMed 15863162Termrungruanglert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saibua B. Chichareon, MD. principal investigator
Thai Gynecologic Oncology Collaborative Group (TGOC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant chemotherapy followed by surgery in people with Cervical Cancer, run by Thai Gynecologic Oncology Collaborative Group at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saibua B. Chichareon, MD. (66 74 451201, saibua.c@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival comparison between experimental treatment group and standard treatment group (time frame: 9 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2010.