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

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.

Sex

All

Minimum age

18 Years

Maximum age

79 Years

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