Cervix CancerNCT03750539
Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer
A study testing Standard radiotherapy, hypofractionated radiotherapy and Radical hysterectomy in people with Cervix Cancer, run by National Institute of Cancerología at 2 sites in Mexico.
Trial summary
The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- Standard radiotherapy, hypofractionated radiotherapy and Radical hysterectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesMexico
- Study dates
- 10 Nov 2017to 10 Nov 2025
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound.
- No distant metastasis via chest X-ray.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age 18
- complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mim3
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- Platelets 100,000 cells/mim3
- Hemoglobin 8.0 g/dl
- White blood count 4000 cell/m3
- An adequate renal function defined as follows:
- Serum creatinine 1.5 mg/dl within 14 days before study entry
- Patients with known HIV positive must have a cluster of differentiation 4 (CD4) T lymphocytes count be 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol). Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before the study enrollment (I took out the ct scan of abdomen and pelvis)
- Patient must provide study-specific informed consent before study entry.
Who cannot join
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity.
- Patients cannot have any neuroendocrine histology in pathology.
- Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable.
- Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.
- Severe active co-morbidity, defined as follows:
- Unstable angina or congestive heart failure requiring hospitalization within the last six months.
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- Transmural myocardial infarction within the previous six months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of the study entry.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry.
- Coagulation defects; note, however, that coagulation parameter are not required for entry into this protocol.
- Prior allergic reaction to cisplatin or other platinum drugs.
- Patients with para-aortic nodes or distant metastasis.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 1 recruiting
- Active, not recruiting
David Cantu de Leon
Mexico City, Tlalpan, 14080
- Recruiting
Instituto Nacional de Cancerologia
Mexico City, 14080
David F Cantu de Leon, MD, PhD, 525556280400 ext. 21016, dfcantu@gmail.com
Lenny N Gallardo-Alvarado, MD, MSc, 525556280400 ext. 37000, dra.ngallardo@yahoo.com
About this study
Official title: Phase II Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.
The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.
Read the detailed description
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effect of hypofractionated radiation therapy on each of these aspects of toxicity from pelvic radiation. Additionally, will be recognized that it is possible to advance in the understanding of the clinical risk and benefits of hypofractionation.
The primary endpoint will be acute gastrointestinal toxicity using the Radiation Therapy Oncology Group (RTOG) common toxicity criteria.
In total, evaluating toxicity in different time points will allow determining if hypofractionation is secure concerning acute and late toxicity, that would enable to offer an optional treatment to this kind of patient. Chronic gastrointestinal toxicity from radiation continues to increase rapidly over two years, and then the rate of developing new toxicities slows. As a result, the majority of chronic radiation-induced gastrointestinal toxicity by evaluating toxicity two years after completion of radiotherapy is going to be identified.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both of which have been validated and available in Mexican Spanish.
- Conditions
- Cervix Cancer
- Being tested
- Standard radiotherapy, hypofractionated radiotherapy, Radical hysterectomy
- 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.
Standard radiotherapyRadiation
External Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin.
hypofractionated radiotherapyRadiation
External Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin.
Radical hysterectomyProcedure or surgery
Also called Surgery
Radical hysterectomy and pelvic and paraaortic lymph node resection
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | External Beam pelvic radiation therapy daily dose of 1.8-2 Gray (Gy) per session for 25 sessions to accomplish 45 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation Receives: Radiation: Standard radiotherapy; Procedure: Radical hysterectomy |
| hypofractionated treatment | Experimental | External Beam pelvic radiation therapy daily dose of 1.8-2gy per session for 15 sessions to accomplish 37.5 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation Receives: Radiation: hypofractionated radiotherapy; Procedure: Radical hysterectomy |
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 (4)
Overall survival
Number of Participants dead at two years according to kaplan-meyer analysis
Measured: 2 years
disease specific survival
Number of Participants dead of disease at two years according to kaplan-meyer analysis
Measured: 2 years
equivalent treatment
hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment.
Measured: 2 years
Surgical complications
comparison of surgical complications between the two arms of treatment according to The Clavien-Dindo classification.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start10 Nov 2017
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix 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
- Model description
- Phase II Comparative Randomized Open-label
- Masking
- None (open label)
- Enrolment
- 100 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 Cantu-de Leon, MD, Msc, PhD, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750539
- Sponsor's protocol ID
- 017/020/ICI
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2018
- 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
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 Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.
- ClinicalTrials.gov ID
- NCT03750539
- Acronym / sponsor ID
- 017/020/ICI
- Conditions
- Cervix Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 23 Nov 2018 (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 purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.
Detailed description
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effect of hypofractionated radiation therapy on each of these aspects of toxicity from pelvic radiation. Additionally, will be recognized that it is possible to advance in the understanding of the clinical risk and benefits of hypofractionation.
The primary endpoint will be acute gastrointestinal toxicity using the Radiation Therapy Oncology Group (RTOG) common toxicity criteria.
In total, evaluating toxicity in different time points will allow determining if hypofractionation is secure concerning acute and late toxicity, that would enable to offer an optional treatment to this kind of patient. Chronic gastrointestinal toxicity from radiation continues to increase rapidly over two years, and then the rate of developing new toxicities slows. As a result, the majority of chronic radiation-induced gastrointestinal toxicity by evaluating toxicity two years after completion of radiotherapy is going to be identified.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both of which have been validated and available in Mexican Spanish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II Comparative Randomized Open-label
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Radiation: Standard radiotherapy, Procedure: Radical hysterectomyExternal Beam pelvic radiation therapy daily dose of 1.8-2 Gray (Gy) per session for 25 sessions to accomplish 45 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation |
| hypofractionated treatment | Experimental | Radiation: hypofractionated radiotherapy, Procedure: Radical hysterectomyExternal Beam pelvic radiation therapy daily dose of 1.8-2gy per session for 15 sessions to accomplish 37.5 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound.
- No distant metastasis via chest X-ray.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age 18
- complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows:
Key exclusion criteria (12 listed)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity.
- Patients cannot have any neuroendocrine histology in pathology.
- Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable.
- Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.
- Severe active co-morbidity, defined as follows:
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 |
|---|---|---|
| Standard radiotherapyExternal Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin. | Radiation | Standard Treatment |
| hypofractionated radiotherapyExternal Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin. | Radiation | hypofractionated treatment |
| Radical hysterectomyAlso: SurgeryRadical hysterectomy and pelvic and paraaortic lymph node resection | Procedure or surgery | Standard Treatment, hypofractionated treatment |
Primary outcome
Acute and late toxicity.
Time frame: 2 years
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
4 secondary outcomes
Overall survival
Time frame: 2 years
disease specific survival
Time frame: 2 years
equivalent treatment
Time frame: 2 years
Surgical complications
Time frame: 1 year
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.
- 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 Cantu-de Leon, MD, Msc, PhD principal investigator
Instituto Nacional de Cancerologia, Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard radiotherapy, hypofractionated radiotherapy and Radical hysterectomy in people with Cervix Cancer, run by National Institute of Cancerología at 2 sites 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 14 inclusion and 12 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 2 sites 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 Cantu-de Leon, MD, MSC, PhD (+5215537093156, 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?
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.