Uterine Cervical NeoplasmsNCT03238261
Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms
A study testing Chemotherapy and concomitant radiotherapy in people with Uterine Cervical Neoplasms, run by Instituto Nacional de Cancerologia, Columbia.
Trial summary
Compare the use of radiotherapy and concomitant chemotherapy, with the single use of radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an outcome the three year survival rate, the disease free survival rate, the locoregional control of the disease and the security of the treatments… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Chemotherapy and concomitant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 1 May 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.
Who cannot join
- Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.
About this study
Official title: CHEMOTHERAPY AND CONCOMITANT RADIOTHERAPY VS. RADIOTHERAPY IN THE TREATMENT OF PATIENTS WITH STAGE IIIB UTERINE CANCER
Compare the use of radiotherapy and concomitant chemotherapy, with the single use of radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an outcome the three year survival rate, the disease free survival rate, the locoregional control of the disease and the security of the treatments provided.
Specific objectives
- Describe and compare the demographic and clinical characteristics of both groups.
- Compare the three year survival rate in both groups.
- Compare the response to treatment in terms of locoregional control of the disease.
- Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.
Read the detailed description
Inclusion criteria Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.
Exclusion criteria Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.
Analysis The descriptive statistical analysis will be made with proportions for the categorical variables, and for numerical variables will be made with averages, medians, standard deviations and ranges. The comparison between categorical variables will be made with square Ji proof or exact Fisher's proof when square Ji proof doesn't meet the criteria. The comparison among continuous variables with normal distribution will be established with T student distribution proof or ANOVA, and Mann-Whitnew or Kruskall proofs will be used for variables that doesn't have this type of distribution.
For the three survival rate, the Kaplan Meier method will be applied, and the survival curves will be compared with the logarithmic range proof. The Cox proportional hazard model is going to be used for the multivariate analysis and to stablish reasons. Additionally 5 interim analysis will be made.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Chemotherapy and concomitant radiotherapy
- 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.
Chemotherapy and concomitant radiotherapyRadiation
Radiotherapy (teletherapy + high or low rate brachytherapy)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and concomitant radiotherapy | Experimental | Not described Receives: Radiation: Chemotherapy and concomitant radiotherapy |
| Radiotherapy | Active comparator | Not described Receives: Radiation: Chemotherapy and concomitant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
the disease free survival rate
Measured: 3 years
Secondary outcomes (2)
The response to treatment in terms of locoregional control of the disease
efficacy
Measured: 3 years
Events adverse
- Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.
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 posted3 Aug 2017
- Study start1 Aug 2007
- Primary completion1 Feb 2012
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238261
- Sponsor's protocol ID
- C41030310-023
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHEMOTHERAPY AND CONCOMITANT RADIOTHERAPY VS. RADIOTHERAPY IN THE TREATMENT OF PATIENTS WITH STAGE IIIB UTERINE CANCER
- ClinicalTrials.gov ID
- NCT03238261
- Acronym / sponsor ID
- C41030310-023
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 1 Feb 2012 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 3 Aug 2017 (actual)
- 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.
Compare the use of radiotherapy and concomitant chemotherapy, with the single use of radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an outcome the three year survival rate, the disease free survival rate, the locoregional control of the disease and the security of the treatments provided.
Specific objectives
- Describe and compare the demographic and clinical characteristics of both groups.
- Compare the three year survival rate in both groups.
- Compare the response to treatment in terms of locoregional control of the disease.
- Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.
Detailed description
Inclusion criteria Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.
Exclusion criteria Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.
Analysis The descriptive statistical analysis will be made with proportions for the categorical variables, and for numerical variables will be made with averages, medians, standard deviations and ranges. The comparison between categorical variables will be made with square Ji proof or exact Fisher's proof when square Ji proof doesn't meet the criteria. The comparison among continuous variables with normal distribution will be established with T student distribution proof or ANOVA, and Mann-Whitnew or Kruskall proofs will be used for variables that doesn't have this type of distribution.
For the three survival rate, the Kaplan Meier method will be applied, and the survival curves will be compared with the logarithmic range proof. The Cox proportional hazard model is going to be used for the multivariate analysis and to stablish reasons. Additionally 5 interim analysis will be made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy and concomitant radiotherapy | Experimental | Radiation: Chemotherapy and concomitant radiotherapy |
| Radiotherapy | Active comparator | Radiation: Chemotherapy and concomitant radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.
Key exclusion criteria (1 listed)
- Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.
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 |
|---|---|---|
| Chemotherapy and concomitant radiotherapyRadiotherapy (teletherapy + high or low rate brachytherapy) | Radiation | Chemotherapy and concomitant radiotherapy, Radiotherapy |
Primary outcome
Survival rate
Time frame: 3 years
the disease free survival rate
2 secondary outcomes
The response to treatment in terms of locoregional control of the disease
Time frame: 3 years
Events adverse
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy and concomitant radiotherapy in people with Uterine Cervical Neoplasms, run by Instituto Nacional de Cancerologia, Columbia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (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 11 Aug 2017.