Carcinoma CervixPhase 3NCT01917695
Study on Early Stage Bulky Cervical Cancers
A Phase 3 study testing Chemotherapy, External Beam Radiotherapy and Brachytherapy in people with Carcinoma Cervix, run by Rajkumar Kottayasamy Seenivasagam at 1 site in India.
Trial summary
The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Carcinoma Cervix
- What is being tested?
- Chemotherapy, External Beam Radiotherapy and Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2013to Aug 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
- Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).
- Age 18-60 years
- Karnofsky performance status of ≥70%; ECOG PS ≤ 2
Who cannot join
- Nonsquamous Histologies
- Other systemic diseases, comorbidities precluding full participation in the study
- Concomitant treatment with any experimental drug
- Pregnant or nursing women
- Previous or concomitant malignant diseases other than non-melanoma skin cancer
- Previous radiation to the pelvis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Government Royapettah Hospital
Chennai, Tamil Nadu, 600014IndiaNaduI6
Rajaraman Ramamurthy, MS MCh, +919444046168, rajaanu1@rediffmail.com
Subbiah Shanmugam, MS MCh, +919360206030, subbiah_doctor@yahoo.co.uk
About this study
Official title: Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)
The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.
Read the detailed description
Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. However, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. The advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. This approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.
The results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai (Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin +Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study ( Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT + Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar results.
With this in mind we are planning to conduct a Phase III Randomised control trial comparing Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical Hysterectomy with concurrent chemoradiation in this subset of cervical cancers
- Conditions
- Carcinoma Cervix
- Being tested
- Chemotherapy, External Beam Radiotherapy, Brachytherapy, Radical Hysterectomy
- Keywords
- Bulky cervical cancers, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
- 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.
ChemotherapyDrug
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
External Beam RadiotherapyRadiation
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
BrachytherapyRadiation
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
Radical HysterectomyProcedure or surgery
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Radical Chemoradiation | Active comparator | Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks Receives: Drug: Chemotherapy; Radiation: External Beam Radiotherapy; Radiation: Brachytherapy |
| Neoadjuvant Chemoradiation + Radical Hysterectomy | Experimental | Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks Receives: Drug: Chemotherapy; Radiation: External Beam Radiotherapy; Procedure: Radical Hysterectomy |
| Neoadjuvant Chemotherapy + Radical Hysterectomy | Experimental | Paclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks Receives: Drug: Chemotherapy; Procedure: Radical Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall and Disease free Survival
Measured: 3 year
Overall and Disease free Survival
Measured: 5 year
Secondary outcomes (3)
Acute Adverse reactions and complications
Measured: Less than 10 weeks
SubAcute Adverse reactions and complications
Measured: 10 weeks - 6 months
Chronic Adverse reactions and complications
Measured: 6 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma CervixStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajkumar Kottayasamy Seenivasagam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rajkumar Kottayasamy Seenivasagam, Government Royapettah Hospital
- Investigators
- Rajaraman Ramamurthy, MS MCh, Study chair, centre for oncology, Government Royapettah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917695
- Sponsor's protocol ID
- GRHCO-01
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)
- ClinicalTrials.gov ID
- NCT01917695
- Acronym / sponsor ID
- GRHCO-01
- Conditions
- Carcinoma Cervix
- Keywords
- Bulky cervical cancers, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rajkumar Kottayasamy SeenivasagamUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 7 Aug 2013 (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 aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.
Detailed description
Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. However, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. The advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. This approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.
The results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai (Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin +Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study ( Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT + Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar results.
With this in mind we are planning to conduct a Phase III Randomised control trial comparing Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical Hysterectomy with concurrent chemoradiation in this subset of cervical cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concurrent Radical Chemoradiation | Active comparator | Drug: Chemotherapy, Radiation: External Beam Radiotherapy, Radiation: BrachytherapyPaclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks |
| Neoadjuvant Chemoradiation + Radical Hysterectomy | Experimental | Drug: Chemotherapy, Radiation: External Beam Radiotherapy, Procedure: Radical HysterectomyPaclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks |
| Neoadjuvant Chemotherapy + Radical Hysterectomy | Experimental | Drug: Chemotherapy, Procedure: Radical HysterectomyPaclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).
- Age 18-60 years
- Karnofsky performance status of ≥70%; ECOG PS ≤ 2
Key exclusion criteria (6 listed)
- Nonsquamous Histologies
- Other systemic diseases, comorbidities precluding full participation in the study
- Concomitant treatment with any experimental drug
- Pregnant or nursing women
- Previous or concomitant malignant diseases other than non-melanoma skin cancer
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 |
|---|---|---|
| Chemotherapycisplatin 75 mg/m2 Paclitaxel 175 mg/m2 | Drug | Concurrent Radical Chemoradiation, Neoadjuvant Chemoradiation + Radical Hysterectomy, Neoadjuvant Chemotherapy + Radical Hysterectomy |
| External Beam Radiotherapy50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5 | Radiation | Concurrent Radical Chemoradiation, Neoadjuvant Chemoradiation + Radical Hysterectomy |
| BrachytherapyIr - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT. | Radiation | Concurrent Radical Chemoradiation |
| Radical HysterectomyType III Radical Hysterectomy + Bilateral Pelvic Node Dissection | Procedure or surgery | Neoadjuvant Chemoradiation + Radical Hysterectomy, Neoadjuvant Chemotherapy + Radical Hysterectomy |
Primary outcome
Overall and Disease free Survival
Time frame: 3 year
Overall and Disease free Survival
Time frame: 5 year
3 secondary outcomes
Acute Adverse reactions and complications
Time frame: Less than 10 weeks
SubAcute Adverse reactions and complications
Time frame: 10 weeks - 6 months
Chronic Adverse reactions and complications
Time frame: 6 months to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Rajaraman Ramamurthy, MS MCh study chair
centre for oncology, Government Royapettah Hospital
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 Chemotherapy, External Beam Radiotherapy and Brachytherapy in people with Carcinoma Cervix, run by Rajkumar Kottayasamy Seenivasagam at 1 site in India.
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 3 inclusion and 6 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 13 Aug 2015. 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 India. 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 Rajaraman Ramamurthy, MS MCh (+919444046168, rajaanu1@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall and Disease free Survival (time frame: 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.