Postsurgery Recurrent Carcinoma CervixPhase 2NCT01117402
Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
A Phase 2 study testing Radiotherapy in people with Postsurgery Recurrent Carcinoma Cervix, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postsurgery Recurrent Carcinoma Cervix
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Dec 2014
- Phase
- Phase 2
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy >3 months without adjuvant treatment
- Patients below 65 years of age and with KPS >70%.
- Patients with disease confined to the pelvis, based on CT/MRI/PET Scan
- Normal ECG and cardiovascular system
- Normal hematological parameters
- Normal renal and liver function tests
Who cannot join
- Previous chemotherapy or radiotherapy to the pelvis
- Pelvic LN >3cm in size
- Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)
- Bilateral hydronephrosis
- Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease
- Medical or Psychological condition that would preclude treatment
- Patient unreliable for treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
Reena Engineer, MD contact
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Reena Engineer, MD, +912224177165, reena_engineer@rediffmail.com
ShyamKishore Shrivastava, MD, +912224177163, shrivastavask@tmc.gov.in
About this study
Official title: Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT \& brachytherapy will achieve higher disease control rates and decrease the complication rates.
Read the detailed description
SPECIFIC OBJECTIVES:
- To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
- To study the late and acute toxicities associated with this treatment.
- Dosimetric comparison of Tomotherapy and conventional IMRT
DESIGN: Prospective, phase II study.
STUDY POPULATION: All patients of age < 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.
STUDY SIZE: 90 patients
METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.
Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.
The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.
PROJECT PERIOD:
Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
- Conditions
- Postsurgery Recurrent Carcinoma Cervix
- Being tested
- Radiotherapy
- Keywords
- recurrent carcinoma cervix, Vault carcinoma, Tomotherapy, Brachytherapy
- 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.
RadiotherapyRadiation
Also called IMRT, Template brachytherapy
Patients will receive external radiation therapy using IMRT to pelvis. Treatment volume (CTV, vault and uninvolved pelvic nodes) will receive a dose of 50-56Gy over 25-28# and gross pelvic nodes will receive 55-62Gy over 25-28 fractions over 5 weeks. Pre RT daily MV CT imaging would be done on Tomotherapy to look and correct for any set up error or anatomic variations.
Chemotherapy will be given weekly - cisplatin 40mg/m2 with prechemo medication. After completion of IMRT all patients will be evaluated for boost to vaginal vault with interstitial template brachytherapy to a dose of 16-20 Gy with HDR in 4-5 fractions. Patients not eligible for brachytherapy will get additional boost to vault and parametrium by EBRT to a dose of 15-20Gy in 6-8 fractions.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control
Progression free survival of all patients
Measured: 3 Years
Secondary outcomes (1)
To study the late toxicities associated with this treatment
Side effects of radiotherapy and chemotherapy will be recorded at baseline, during treatment, at 6 and 12 months and annually thereafter according to the RTOG scales
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgery Recurrent 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Reena Engineer, MD, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117402
- Sponsor's protocol ID
- IRB 588
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
- ClinicalTrials.gov ID
- NCT01117402
- Acronym / sponsor ID
- IRB 588
- Conditions
- Postsurgery Recurrent Carcinoma Cervix
- Keywords
- recurrent carcinoma cervix, Vault carcinoma, Tomotherapy, Brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Dec 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 May 2010 (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.
Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT \& brachytherapy will achieve higher disease control rates and decrease the complication rates.
Detailed description
SPECIFIC OBJECTIVES:
- To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
- To study the late and acute toxicities associated with this treatment.
- Dosimetric comparison of Tomotherapy and conventional IMRT
DESIGN: Prospective, phase II study.
STUDY POPULATION: All patients of age < 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.
STUDY SIZE: 90 patients
METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.
Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.
The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.
PROJECT PERIOD:
Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- . Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy >3 months without adjuvant treatment
- Patients below 65 years of age and with KPS >70%.
- Patients with disease confined to the pelvis, based on CT/MRI/PET Scan
- Normal ECG and cardiovascular system
- Normal hematological parameters
Key exclusion criteria (7 listed)
- Previous chemotherapy or radiotherapy to the pelvis
- Pelvic LN >3cm in size
- Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)
- Bilateral hydronephrosis
- Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease
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 |
|---|---|---|
| RadiotherapyAlso: IMRT, Template brachytherapyPatients will receive external radiation therapy using IMRT to pelvis. Treatment volume (CTV, vault and uninvolved pelvic nodes) will receive a dose of 50-56Gy over 25-28# and gross pelvic nodes will receive 55-62Gy over 25-28 fractions over 5 weeks. Pre RT daily MV CT imaging would be done on Tomotherapy to look and correct for any set up error or anatomic variations. Chemotherapy will be given weekly - cisplatin 40mg/m2 with prechemo medication. After completion of IMRT all patients will be evaluated for boost to vaginal vault with interstitial template brachytherapy to a dose of 16-20 Gy with HDR in 4-5 fractions. Patients not eligible for brachytherapy will get additional boost to vault and parametrium by EBRT to a dose of 15-20Gy in 6-8 fractions. | Radiation | – |
Primary outcome
To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control
Time frame: 3 Years
Progression free survival of all patients
1 secondary outcome
To study the late toxicities associated with this treatment
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
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.
Reena Engineer, MD contact
Reena Engineer, MD principal investigator
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy in people with Postsurgery Recurrent Carcinoma Cervix, run by Tata Memorial Hospital 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 6 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 5 May 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Reena Engineer, MD (+912224177165), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control (time frame: 3 Years). 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 5 May 2010.