Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Prostatic Neoplasms

Vaginal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Genital Neoplasms, Female

Vaginal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Uterine Diseases

Vaginal Cancer

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

Biological investigations

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.

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.

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

* Haemoglobin
* Platelets
* Neutrophils
* Lymphocytes

Institut de cancérologie Strasbourg Europe

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Michela Buglione, Prof

The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT).

The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.

Clinical features and outcomes of the patients included in the study will be assessed as better detailed in the following lines:

1. To define the diffusion of the practice of treating pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer (PCa) among Italian Radiation Oncology Centers, submitted to radical or post-operative radiotherapy;
2. To define the diffusion of the different radiotherapy techniques used to treat pelvic nodes and the other features of the radiation treatment;
3. To register prospectively biochemical and clinical failure, prostate cancer deaths and deaths for any cause in the population studied;
4. To register prospectively the toxicity due to radiotherapy and androgen deprivation therapy in patients treated with pelvic nodes radiotherapy;
5. To compare clinical outcomes and toxicities observed in the different clinical and therapeutic subgroups with the corresponding historical data relative to PCa patients treated with radiotherapy with or without elective pelvic nodal irradiation, already available in the existing Italian Society of Radiation Oncology databases;
6. To exploit the collected data to define the need and the features of a prospective randomized trial evaluating the efficacy of elective pelvic nodal irradiation in patients with intermediate/high/very high risk non-metastatic prostate cancer.

PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer

Evaluate the number of patients treated with RT on pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer

Analyze the number of patients treated with 3Dconformal Radiotherapy (3DCRT), Intensity Modulated Radiation Therapy (IMRT), Volumetric arch Therapy (VMAT), Tomotherapy, respectively with/without Image Guided Radiotherapy (IGRT) for pelvic irradiation

register, using CTCAE v.4 acute and late urinary and rectal toxicities in the groups of patients treated with/without pelvic irradiation.

Using chi-square test compare toxicities and clinical outcome in the different groups of patients.

Takeda

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Prof

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Cetuximab

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Pelvic irradiation plus 5-fluorouracil plus cetuximab

5-fluorouracil

Pelvic irradiation

Andrew D McCollum, MD

The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.

Rectal cancer remains a significant cause of morbidity and mortality in the United States. Standard treatment for patients with locally advanced rectal cancer generally includes combined chemotherapy and radiotherapy administered either before (neoadjuvant) or after (adjuvant) definitive surgical resection. Published data from Germany has suggested advantages to a neoadjuvant strategy. Currently, the standard concurrent chemoradiotherapy regimen in the United States is pelvic irradiation administered concurrently with 5-fluorouracil (5-FU) given as a protracted venous infusion. However, local recurrence remains a problem. Recently completed randomized trials of chemoradiotherapy have demonstrated local recurrence rates between 8-17% even with currently accepted standard chemoradiotherapy and adequate surgical management.

Several recent trials have explored the use of radiotherapy and cetuximab with good results.

Because of the non-overlapping toxicity profiles and the potentially diverse and complimentary mechanisms of action, the combination of chemotherapy plus ERBITUX given concurrently with pelvic radiotherapy may improve on the outcomes seen with current standards for patients with locally advanced adenocarcinoma of the rectum.

Pre-op Rectal ChemoRad +/- Cetuximab

A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum

A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.

RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.

Percentage of Participants with KRAS mutation.

Bristol-Myers Squibb

Eli Lilly and Company

US Oncology Research

For treatment patients only, assessed at each treatment visit.

Pelvic irradiation plus 5-fluorouracil plus cetuximab

Cetuximab

5-fluorouracil

Pelvic irradiation

Chemoradiotherapy Plus Cetuximab

Pelvic irradiation plus 5-fluorouracil

5-fluorouracil

Pelvic irradiation

Chemoradiotherapy Alone

Total

Age, Continuous

Sex: Female, Male

Caucasian

Black

Hispanic

Asian

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. David McCollum

Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.

To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.

5- Year Overall Survival (OS) Rate

Recurrence-free Survival (RFS) Rate at 5 Years

KRAS Mutation Rate

Overall Study

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.

CTV covers pelvis and para-aortic lymph nodes region.

Prophylactic extended-field Irradiation

The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.

Intracavitary brachytherapy

Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.

Concurrent chemotherapy

Ke Hu

Ke Hu, MD

Weiping Wang, PhD

Zi Liu

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.

Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial

Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

Overall survival is calculated from randomization to death from any cause.

Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.

The incidence of para-aortic lymph nodes failure.

Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Prostate Carcin... Rectum Carcinom... Anal Canal Carc... Endometrium Car... Cervix Carcinom... Radiotherapy Vaginal Cancer	Biological inve...	18 Years - 79 Years	Institut de cancérologie Strasbourg Europe
PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.	NCT03340272	Intermediate Ri... High Risk Prost...		18 Years -	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Pre-op Rectal ChemoRad +/- Cetuximab	NCT00527111	Rectal Cancer	Cetuximab 5-fluorouracil Pelvic irradiat...	18 Years -	US Oncology Research
Pre-op Rectal ChemoRad +/- Cetuximab	NCT00527111	Rectal Cancer	Cetuximab 5-fluorouracil Pelvic irradiat...	18 Years -	US Oncology Research
Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer	NCT03955367	Uterine Cervica...	Prophylactic ex... Pelvic irradiat... Intracavitary b... Concurrent chem...	18 Years - 70 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for pelvic irradiation