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

NCT04626466 | Completed

• 2 other identifiers: 2020-0042020-A01108-31
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Carcinoma; Rectum Carcinoma; Anal Canal Carcinoma; Endometrium Carcinoma; Cervix Carcinoma; Radiotherapy; Vaginal Cancer

Keywords

Bone marrow; Hematologic toxicity; Pelvic irradiation; Radiotherapy; Intensity-modulated radiotherapy (IMRT)

Outcome Measures

Primary Outcomes (3)

• Assessment of acute haematological toxicity according to CTCAE v5.0

  * Haemoglobin * Platelets * Neutrophils * Lymphocytes

  throughout radiotherapy treatment

• Assessment of acute haematological toxicity according to CTCAE v5.0

  * Haemoglobin * Platelets * Neutrophils * Lymphocytes

  1 month after the end of radiotherapy

• Assessment of acute haematological toxicity according to CTCAE v5.0

  * Haemoglobin * Platelets * Neutrophils * Lymphocytes

  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

  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

Study Arms (1)

Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment

Other: Biological investigations

Interventions

Biological investigations OTHER

(complete blood count, platelet count, renal function evaluation)

Non-metastatic prostate, rectum, canal, endometrium, cervix or vaginal cancer Radiotherapy treatment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Signed informed consent from the patient

You may not qualify if:

• History of haematologic disorders, leucopathia or imune system diseases
• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (3)

CHRU Jean Minjoz

Besançon, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Rectal Neoplasms; Anal Canal Carcinoma; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Cervical Diseases; Vaginal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 12, 2020
• Study Start: August 3, 2020
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

FR (3)