Cervical CancerNCT04070976
Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer
A study testing Hypofractionated therapy and Standard therapy in people with Cervical Cancer, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Hypofractionated therapy and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2019to 30 Dec 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years old
- Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
- Histology: squamous, adenosquamous or adenocarcinoma
- No previous treatment
- No distance metastases, discard by Positron Emission Tomography (PET)/CT
- Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
Show all 16Show fewer
- Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:
- Absolute neutrophil count ≥ 1,500 cell/mm3
- Platelets ≥ 100,000 cell/mm3
- Hemoglobin ≥ 10.0 g/dl
- Leukocyte count ≥ 4000 cell/mm3
- Adequate Renal Function defined as:
- Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study
- Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)
- The patient must understand the protocol and provide the specific informed consent of the study before admission
- Negative pregnancy test
Who cannot join
- Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
- Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
- Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
- Severe active or non-controlled co-morbidities, defined as:
- Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
- Transmural myocardial infarction in the last 6 months.
Show all 11Show fewer
- Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.
- Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.
- Crohn's disease or ulcerative colitis.
- Prior allergic reaction to cisplatin or other drugs based on platinum.
- Other factors that contraindicate experimental therapy.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
David Cantu de Leon
Mexico City, Tlalpan, 14080
David F Cantu-de Leon, MD. Msc. Phd, +5215537093116, dfcantu@gmail.com
About this study
Official title: Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients
The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.
Read the detailed description
The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs.
The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish.
Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.
- Conditions
- Cervical Cancer
- Being tested
- Hypofractionated therapy, Standard therapy
- Keywords
- hypofractionated radiotherapy, 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.
Hypofractionated therapyRadiation
All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Standard therapyRadiation
All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Cisplatin 40mg/m2 weekly and concomitant pelvic radiotherapy (45 Gray/25 fractions) followed by brachytherapy 28Gray at point A. Receives: Radiation: Standard therapy |
| Experimental treatment | Experimental | Cisplatin 40mg/m2 weekly and hypofractionated concomitant external radiotherapy (37,50 Gray/15 fractions) followed by brachytherapy 28 Gray at point A. Receives: Radiation: Hypofractionated therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late toxicity
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
Measured: 2 years
Secondary outcomes (5)
Treatment efficacy
Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment
Measured: 2 years
Disease-free survival rate
Number of participants dead of disease at two years according to kaplan-meyer analysis
Measured: 2 years
Overall survival rate
Number ofpParticipants dead at two years according to kaplan-meyer analysis
Measured: 2 years
Satisfaction assessed by EORTC
Assessed individual's overall satisfaction with life and general sense of personal well-being by ERTC QLQ-C30 and QLQ-CX24 questionaire
Measured: 2 years
Direct and indirect costs related to treatment.
Direct costs related to the treatment. Indirect costs related to the treatment (transport, housing, food, etc.)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jul 2019
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Cantu, National Institute of Cancerología
- Investigators
- David F Cantú-deLeón, Principal investigator, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070976
- Sponsor's protocol ID
- 019/036/ICI
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Gosvig CF, Huusom LD, Andersen KK, Duun-Henriksen AK, Frederiksen K, Iftner A, Svare E, Iftner T, Kjaer SK. Long-term follow-up of the risk for cervical intraepithelial neoplasia grade 2 or worse in HPV-negative women after conization. Int J Cancer. 2015 Dec 15;137(12):2927-33. doi: 10.1002/ijc.29673. Epub 2015 Jul 25.
PubMed 26139420Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
PubMed 10202164Carlson RW, Scavone JL, Koh WJ, McClure JS, Greer BE, Kumar R, McMillian NR, Anderson BO. NCCN Framework for Resource Stratification: A Framework for Providing and Improving Global Quality Oncology Care. J Natl Compr Canc Netw. 2016 Aug;14(8):961-9. doi: 10.6004/jnccn.2016.0103.
PubMed 27496112Robin TP, Amini A, Schefter TE, Behbakht K, Fisher CM. Disparities in standard of care treatment and associated survival decrement in patients with locally advanced cervical cancer. Gynecol Oncol. 2016 Nov;143(2):319-325. doi: 10.1016/j.ygyno.2016.09.009. Epub 2016 Sep 16.
PubMed 27640961Greenup RA, Blitzblau RC, Houck KL, Sosa JA, Horton J, Peppercorn JM, Taghian AG, Smith BL, Hwang ES. Cost Implications of an Evidence-Based Approach to Radiation Treatment After Lumpectomy for Early-Stage Breast Cancer. J Oncol Pract. 2017 Apr;13(4):e283-e290. doi: 10.1200/JOP.2016.016683. Epub 2017 Mar 14.
PubMed 28291382Muckaden MA, Budrukkar AN, Tongaonkar HB, Dinshaw KA. Hypofractionated radiotherapy in carcinoma cervix IIIB: Tata Memorial Hospital experience. Indian J Cancer. 2002 Oct-Dec;39(4):127-34.
PubMed 12928570Zhang H, Wang JZ, Mayr N, Kong X, Yuan J, Gupta N, Lo S, Grecula J, Montebello J, Martin D, Yuh W. Fractionated grid therapy in treating cervical cancers: conventional fractionation or hypofractionation? Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):280-8. doi: 10.1016/j.ijrobp.2007.08.024. Epub 2007 Oct 29.
PubMed 17967516Hoffman KE, Voong KR, Pugh TJ, Skinner H, Levy LB, Takiar V, Choi S, Du W, Frank SJ, Johnson J, Kanke J, Kudchadker RJ, Lee AK, Mahmood U, McGuire SE, Kuban DA. Risk of late toxicity in men receiving dose-escalated hypofractionated intensity modulated prostate radiation therapy: results from a randomized trial. Int J Radiat Oncol Biol Phys. 2014 Apr 1;88(5):1074-84. doi: 10.1016/j.ijrobp.2014.01.015.
PubMed 24661661Antoni S, Soerjomataram I, Moller B, Bray F, Ferlay J. An assessment of GLOBOCAN methods for deriving national estimates of cancer incidence. Bull World Health Organ. 2016 Mar 1;94(3):174-84. doi: 10.2471/BLT.15.164384. Epub 2016 Jan 28.
PubMed 26966328Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.
PubMed 30350310Bhatla N, Aoki D, Sharma DN, Sankaranarayanan R. Cancer of the cervix uteri. Int J Gynaecol Obstet. 2018 Oct;143 Suppl 2:22-36. doi: 10.1002/ijgo.12611.
PubMed 30306584FIGO Committee on Gynecologic Oncology. FIGO staging for carcinoma of the vulva, cervix, and corpus uteri. Int J Gynaecol Obstet. 2014 May;125(2):97-8. doi: 10.1016/j.ijgo.2014.02.003. Epub 2014 Feb 22. No abstract available.
PubMed 24630859Chuang LT, Temin S, Camacho R, Duenas-Gonzalez A, Feldman S, Gultekin M, Gupta V, Horton S, Jacob G, Kidd EA, Lishimpi K, Nakisige C, Nam JH, Ngan HYS, Small W, Thomas G, Berek JS. Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline. J Glob Oncol. 2016 May 25;2(5):311-340. doi: 10.1200/JGO.2016.003954. eCollection 2016 Oct.
PubMed 28717717
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT04070976
- Acronym / sponsor ID
- 019/036/ICI
- Conditions
- Cervical Cancer
- Keywords
- hypofractionated radiotherapy, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Aug 2019 (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.
The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.
Detailed description
The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs.
The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish.
Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Radiation: Standard therapyCisplatin 40mg/m2 weekly and concomitant pelvic radiotherapy (45 Gray/25 fractions) followed by brachytherapy 28Gray at point A. |
| Experimental treatment | Experimental | Radiation: Hypofractionated therapyCisplatin 40mg/m2 weekly and hypofractionated concomitant external radiotherapy (37,50 Gray/15 fractions) followed by brachytherapy 28 Gray at point A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women over 18 years old
- Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
- Histology: squamous, adenosquamous or adenocarcinoma
- No previous treatment
- No distance metastases, discard by Positron Emission Tomography (PET)/CT
Key exclusion criteria (11 listed)
- Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
- Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
- Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
- Severe active or non-controlled co-morbidities, defined as:
- Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
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 |
|---|---|---|
| Hypofractionated therapyAll patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams. | Radiation | Experimental treatment |
| Standard therapyAll patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams. | Radiation | Standard treatment |
Primary outcome
Acute and late toxicity
Time frame: 2 years
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
5 secondary outcomes
Treatment efficacy
Time frame: 2 years
Disease-free survival rate
Time frame: 2 years
Overall survival rate
Time frame: 2 years
Satisfaction assessed by EORTC
Time frame: 2 years
Direct and indirect costs related to treatment.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 26139420Gosvig CF, Huusom LD, Andersen KK, Duun-Henriksen AK, Frederiksen K, Iftner A, Svare E, Iftner T, Kjaer SK. Long-term follow-up of the risk for cervical intraepithelial neoplasia grade 2 or worse in HPV-negative women after conization. Int J Cancer. 2015 Dec 15;137(12):2927-33. doi: 10.1002/ijc.29673. Epub 2015 Jul 25.
- Background: PubMed 10202164Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
- Background: PubMed 27496112Carlson RW, Scavone JL, Koh WJ, McClure JS, Greer BE, Kumar R, McMillian NR, Anderson BO. NCCN Framework for Resource Stratification: A Framework for Providing and Improving Global Quality Oncology Care. J Natl Compr Canc Netw. 2016 Aug;14(8):961-9. doi: 10.6004/jnccn.2016.0103.
- Background: PubMed 27640961Robin TP, Amini A, Schefter TE, Behbakht K, Fisher CM. Disparities in standard of care treatment and associated survival decrement in patients with locally advanced cervical cancer. Gynecol Oncol. 2016 Nov;143(2):319-325. doi: 10.1016/j.ygyno.2016.09.009. Epub 2016 Sep 16.
- Background: PubMed 28291382Greenup RA, Blitzblau RC, Houck KL, Sosa JA, Horton J, Peppercorn JM, Taghian AG, Smith BL, Hwang ES. Cost Implications of an Evidence-Based Approach to Radiation Treatment After Lumpectomy for Early-Stage Breast Cancer. J Oncol Pract. 2017 Apr;13(4):e283-e290. doi: 10.1200/JOP.2016.016683. Epub 2017 Mar 14.
- Background: PubMed 12928570Muckaden MA, Budrukkar AN, Tongaonkar HB, Dinshaw KA. Hypofractionated radiotherapy in carcinoma cervix IIIB: Tata Memorial Hospital experience. Indian J Cancer. 2002 Oct-Dec;39(4):127-34.
- Background: PubMed 17967516Zhang H, Wang JZ, Mayr N, Kong X, Yuan J, Gupta N, Lo S, Grecula J, Montebello J, Martin D, Yuh W. Fractionated grid therapy in treating cervical cancers: conventional fractionation or hypofractionation? Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):280-8. doi: 10.1016/j.ijrobp.2007.08.024. Epub 2007 Oct 29.
- Background: PubMed 24661661Hoffman KE, Voong KR, Pugh TJ, Skinner H, Levy LB, Takiar V, Choi S, Du W, Frank SJ, Johnson J, Kanke J, Kudchadker RJ, Lee AK, Mahmood U, McGuire SE, Kuban DA. Risk of late toxicity in men receiving dose-escalated hypofractionated intensity modulated prostate radiation therapy: results from a randomized trial. Int J Radiat Oncol Biol Phys. 2014 Apr 1;88(5):1074-84. doi: 10.1016/j.ijrobp.2014.01.015.
- Background: PubMed 26966328Antoni S, Soerjomataram I, Moller B, Bray F, Ferlay J. An assessment of GLOBOCAN methods for deriving national estimates of cancer incidence. Bull World Health Organ. 2016 Mar 1;94(3):174-84. doi: 10.2471/BLT.15.164384. Epub 2016 Jan 28.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 30350310Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.
- Human papillomavirus (HPV) and cervical cancer \[Internet\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
David F Cantú-deLeón principal investigator
Instituto Nacional de Cancerologia de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated therapy and Standard therapy in people with Cervical Cancer, run by National Institute of Cancerología at 1 site in Mexico.
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 16 inclusion and 11 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 14 Nov 2023. 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 Mexico. 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.
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 David F Cantú-de León, Md, MSc. PhD (+525537093156, dfcantu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and late toxicity (time frame: 2 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 NCT04070976, which also lists 20 linked publications.
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 14 Nov 2023.