MIFADORESOL: 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

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Recruiting

CT.gov ID

NCT04626466

Collaborator

(none)

100

Enrollment

Locations

25.9

Anticipated Duration (Months)

33.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Carcinoma Rectum Carcinoma Anal Canal Carcinoma Endometrium Carcinoma Cervix Carcinoma Radiotherapy Vaginal Cancer	Other: Biological investigations

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 3, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Assessment of acute haematological toxicity according to CTCAE v5.0 [throughout radiotherapy treatment]
Haemoglobin Platelets Neutrophils Lymphocytes
Assessment of acute haematological toxicity according to CTCAE v5.0 [1 month after the end of radiotherapy]
Haemoglobin Platelets Neutrophils Lymphocytes
Assessment of acute haematological toxicity according to CTCAE v5.0 [3 months after the end of radiotherapy]
Haemoglobin Platelets Neutrophils Lymphocytes

Secondary Outcome Measures

Number of patients with clinical signs of viral, bacterial, or fungal infections according to CTCAE v5.0 [throughout treatment, at 1 and 3 months]
Number of patients undergoing definitive and transient discontinuations of concomitant chemotherapy. [throughout treatment, at 1 and 3 months]
Number of patients who required a reduction in chemotherapy dose. [throughout treatment, at 1 and 3 months]
Cumulative doses and theoretical doses of chemotherapy. [throughout treatment, at 1 and 3 months]
Number of patients undergoing definitive withdrawal or transitory stops of the entire treatment. [throughout treatment, at 1 and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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