Prostate CarcinomaMIFADORESOLNCT04626466
Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation
An observational study of Prostate Carcinoma and Rectum Carcinoma, run by Institut de cancérologie Strasbourg Europe at 3 sites in France.
Trial summary
Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Prostate Carcinoma, Rectum Carcinoma, Anal Canal Carcinoma
- What is being tested?
- Biological investigations
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Aug 2020to 2 Jan 2024
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-metastatic prostate, rectum, anal canal, endometrium, cervix carcinoma or vaginal cancer Radiotherapy treatment validated in a multidisciplinary consultation meeting
Who may be able to join
- Patients must be ≥ 18 years old and < 80 years old
- Performance Status 0 to 2
- Histologically-confirmed diagnosis of : prostate cancer ; cervical cancer ; vaginal cancer ; endometrial cancer ; middle or low rectal cancer ; anal duct carcinoma
- At inclusion, patients must have : Haemoglobin > 10 g/dL ; Leucocytes 4.0-11.0 g/L ; Neutrophils 1.5-7.7 g/L ; Platelets 150-400 g/L
- Signed informed consent from the patient
Who cannot join
- History of haematologic disorders, leucopathia or imune system diseases
- At inclusion, patients must not have : Haemoglobin < 10 g/dL or > 18 g/dL (men) > 16 g/dL (women) ; Leucocytes < 4.0 or > 11.0 g/L ; Neutrophils < 1.5 or > 7.7 g/L ; Platelets < 150 or > 400 g/L
- Patients previously treated with radiation therapy or with chemotherapy
- Patients with metastatic cancer
- Patients presenting tumor classified histologically as sarcomatoid
- Patients placed under judicial protection, guardianship, or supervision
- Women that are pregnant or breast-feeding
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU Jean Minjoz
Besançon
Centre Georges François Leclerc
Dijon
Institut de Cancerologie Strasbourg Europe
Strasbourg, 67033
About this study
Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.
Read the detailed description
Patients will be identified as potentially eligible for inclusion once radiotherapy has been decided upon at the multidisciplinary consultation meeting. During the radiotherapy consultation, the study will be offered to the patient if they also meet the other inclusion criteria. As soon as the consent is signed and before the first radiotherapy session, a first biological check-up including a blood count and renal function will be performed. This biological investigation will serve as a reference.
During the dosimetric computer-tomography scan for radiotherapy, bony structures will be delineated, iliac bones, lower pelvis, femoral heads, lumbosacral spine and entire pelvis.
Dosimetry will be performed in the same way whether patients are included in the study or not, they will receive between 25Gy in 5 fractions and 78Gy in 39 fractions, depending on the primary tumor. The dose volume histograms will be received.
During treatment, patients will have a weekly blood test starting from the second week of treatment. At one months and three months after the end of the radiotherapy, patients will be seen in consultation and will also have a blood test.
- Conditions
- Prostate Carcinoma, Rectum Carcinoma, Anal Canal Carcinoma, Endometrium Carcinoma, Cervix Carcinoma, Radiotherapy
- Being tested
- Biological investigations
- Keywords
- Bone marrow, Hematologic toxicity, Pelvic irradiation, Radiotherapy, Intensity-modulated radiotherapy (IMRT)
- Medical subject headings
- Prostatic Neoplasms, Rectal Neoplasms, Anal Canal Carcinoma, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological investigationsOther
(complete blood count, platelet count, renal function evaluation)
| Study group | Role | What they receive |
|---|---|---|
| Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment | Not described Receives: Other: Biological investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of acute haematological toxicity according to CTCAE v5.0
- Haemoglobin
- Platelets
- Neutrophils
- Lymphocytes
Measured: throughout radiotherapy treatment
Assessment of acute haematological toxicity according to CTCAE v5.0
- Haemoglobin
- Platelets
- Neutrophils
- Lymphocytes
Measured: 1 month after the end of radiotherapy
Assessment of acute haematological toxicity according to CTCAE v5.0
- Haemoglobin
- Platelets
- Neutrophils
- Lymphocytes
Measured: 3 months after the end of radiotherapy
Secondary outcomes (5)
Number of patients with clinical signs of viral, bacterial, or fungal infections according to CTCAE v5.0
Measured: throughout treatment, at 1 and 3 months
Number of patients undergoing definitive and transient discontinuations of concomitant chemotherapy.
Measured: throughout treatment, at 1 and 3 months
Number of patients who required a reduction in chemotherapy dose.
Measured: throughout treatment, at 1 and 3 months
Cumulative doses and theoretical doses of chemotherapy.
Measured: throughout treatment, at 1 and 3 months
Number of patients undergoing definitive withdrawal or transitory stops of the entire treatment.
Measured: throughout treatment, at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start3 Aug 2020
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626466
- Sponsor's protocol ID
- 2020-004
- Other IDs
- 2020-A01108-31
- Acronym
- MIFADORESOL
- Status last verified
- Jan 2024
- First submitted
- 3 Nov 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation
- ClinicalTrials.gov ID
- NCT04626466
- Acronym / sponsor ID
- MIFADORESOL / 2020-004
- Conditions
- Prostate Carcinoma, Rectum Carcinoma, Anal Canal Carcinoma, Endometrium Carcinoma, Cervix Carcinoma, Radiotherapy
- Keywords
- Bone marrow, Hematologic toxicity, Pelvic irradiation, Radiotherapy, Intensity-modulated radiotherapy (IMRT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Nov 2020 (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.
Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.
Detailed description
Patients will be identified as potentially eligible for inclusion once radiotherapy has been decided upon at the multidisciplinary consultation meeting. During the radiotherapy consultation, the study will be offered to the patient if they also meet the other inclusion criteria. As soon as the consent is signed and before the first radiotherapy session, a first biological check-up including a blood count and renal function will be performed. This biological investigation will serve as a reference.
During the dosimetric computer-tomography scan for radiotherapy, bony structures will be delineated, iliac bones, lower pelvis, femoral heads, lumbosacral spine and entire pelvis.
Dosimetry will be performed in the same way whether patients are included in the study or not, they will receive between 25Gy in 5 fractions and 78Gy in 39 fractions, depending on the primary tumor. The dose volume histograms will be received.
During treatment, patients will have a weekly blood test starting from the second week of treatment. At one months and three months after the end of the radiotherapy, patients will be seen in consultation and will also have a blood test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment | – | Other: Biological investigations |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-metastatic prostate, rectum, anal canal, endometrium, cervix carcinoma or vaginal cancer Radiotherapy treatment validated in a multidisciplinary consultation meeting
Key inclusion criteria (5 listed)
- Patients must be ≥ 18 years old and < 80 years old
- Performance Status 0 to 2
- Histologically-confirmed diagnosis of : prostate cancer ; cervical cancer ; vaginal cancer ; endometrial cancer ; middle or low rectal cancer ; anal duct carcinoma
- At inclusion, patients must have : Haemoglobin > 10 g/dL ; Leucocytes 4.0-11.0 g/L ; Neutrophils 1.5-7.7 g/L ; Platelets 150-400 g/L
- Signed informed consent from the patient
Key exclusion criteria (7 listed)
- History of haematologic disorders, leucopathia or imune system diseases
- At inclusion, patients must not have : Haemoglobin < 10 g/dL or > 18 g/dL (men) > 16 g/dL (women) ; Leucocytes < 4.0 or > 11.0 g/L ; Neutrophils < 1.5 or > 7.7 g/L ; Platelets < 150 or > 400 g/L
- Patients previously treated with radiation therapy or with chemotherapy
- Patients with metastatic cancer
- Patients presenting tumor classified histologically as sarcomatoid
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 |
|---|---|---|
| Biological investigations(complete blood count, platelet count, renal function evaluation) | Other | Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment |
Primary outcome
Assessment of acute haematological toxicity according to CTCAE v5.0
Time frame: throughout radiotherapy treatment
* Haemoglobin * Platelets * Neutrophils * Lymphocytes
Assessment of acute haematological toxicity according to CTCAE v5.0
Time frame: 1 month after the end of radiotherapy
* Haemoglobin * Platelets * Neutrophils * Lymphocytes
Assessment of acute haematological toxicity according to CTCAE v5.0
Time frame: 3 months after the end of radiotherapy
* Haemoglobin * Platelets * Neutrophils * Lymphocytes
5 secondary outcomes
Number of patients with clinical signs of viral, bacterial, or fungal infections according to CTCAE v5.0
Time frame: throughout treatment, at 1 and 3 months
Number of patients undergoing definitive and transient discontinuations of concomitant chemotherapy.
Time frame: throughout treatment, at 1 and 3 months
Number of patients who required a reduction in chemotherapy dose.
Time frame: throughout treatment, at 1 and 3 months
Cumulative doses and theoretical doses of chemotherapy.
Time frame: throughout treatment, at 1 and 3 months
Number of patients undergoing definitive withdrawal or transitory stops of the entire treatment.
Time frame: throughout treatment, at 1 and 3 months
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 Jan 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma and Rectum Carcinoma, run by Institut de cancérologie Strasbourg Europe at 3 sites in France.
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 5 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
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?
Assessment of acute haematological toxicity according to CTCAE v5.0 (time frame: throughout radiotherapy treatment). The study lists 3 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 11 Jan 2024.