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 (MIFADORESOL)

January 10, 2024 updated by: Institut de cancérologie Strasbourg Europe
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France
        • CHRU Jean Minjoz
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Non-metastatic prostate, rectum, anal canal, endometrium, cervix carcinoma or vaginal cancer Radiotherapy treatment validated in a multidisciplinary consultation meeting

Description

For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria :

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment
Other: Biological investigations
(complete blood count, platelet count, renal function evaluation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of acute haematological toxicity according to CTCAE v5.0
Time Frame: throughout radiotherapy treatment
  • Haemoglobin
  • Platelets
  • Neutrophils
  • Lymphocytes
throughout radiotherapy treatment
Assessment of acute haematological toxicity according to CTCAE v5.0
Time Frame: 1 month after the end of radiotherapy
  • Haemoglobin
  • Platelets
  • Neutrophils
  • Lymphocytes
1 month after the end of radiotherapy
Assessment of acute haematological toxicity according to CTCAE v5.0
Time Frame: 3 months after the end of radiotherapy
  • Haemoglobin
  • Platelets
  • Neutrophils
  • Lymphocytes
3 months after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
throughout treatment, at 1 and 3 months
Cumulative doses and theoretical doses of chemotherapy.
Time Frame: throughout treatment, at 1 and 3 months
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
throughout treatment, at 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

January 2, 2024

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-004
  • 2020-A01108-31 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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