NCT04626466Completed
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
Source: ClinicalTrials.gov · Last updated 11 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 3 Nov 2020
- Start date
- 3 Aug 2020
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Diseases
- Prostate cancer, Cervical cancer, Colorectal cancer
- NCT number
- NCT04626466
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 3 Aug 2020 to the primary completion date, 2 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with radiation therapy or with chemotherapy
Other illness
- History of haematologic disorders, leucopathia or imune system diseases
- Patients with metastatic cancer
Lab values
- 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
Other
- Patients presenting tumor classified histologically as sarcomatoid
- Patients placed under judicial protection, guardianship, or supervision
- Women that are pregnant or breast-feeding
Who the study is looking for
- 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
Criteria the registry did not label
- For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria :
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.