Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Uterine Cervical Neoplasms

Carcinoma, Adenosquamous

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Amifostine

Protective Agents

Radiation-Protective Agents

Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.

Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.

Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.

Amifostine trihydrate

Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m\^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy.

Intracavitary brachytherapy

Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%.

External beam radiation therapy

William Small, MD

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.

OBJECTIVES:

* Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
* Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
* Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.

OUTLINE:

* Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
* Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer

A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy And Amifostine In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes

To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.

The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).

Radiation Therapy Plus Cisplatin

Radiation Therapy Plus Cisplatin & Amifostine

Total

Age, Continuous

Sex: Female, Male

Wendy Seiferheld

Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)

Radiation Therapy Plus Cisplatin and Amifostine

Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)

Pelvic Tumor Control

Distant Metastases

Overall Study

MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.

Computed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.

MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.

Intracavitary Applicator Placement

CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.

Computed Tomography (CT)

MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.

Magnetic Resonance Imaging (MRI)

Ann Klopp, MD

The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.

Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes.

Study Procedures:

If you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used.

You will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant.

The additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan.

Length of Study:

Your active participation on this study will be complete once you have the CT and MRI scans.

Your medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future.

This is an investigational study. The applicator that best fits your personal anatomy will be used in this study. A selection of MRI compatible applicators are available. Many of the MRI applicators that will be used are FDA approved. However, in some cases you may have a novel device with a moveable shield placed. This applicator is not FDA approved or commercially available.

Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator

Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer

Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.

MRI-based brachytherapy planning for patients with tumors \>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI

RI-adaptive applicators for treatment planning for every case/patient.

Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.

To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.

The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.

M.D. Anderson Cancer Center

Single Arm study in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.

Experimental Brachytherapy Treatment Planning

Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.

Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ann Klopp / Associate Professor, Radiation Oncology

Standard Position

Shifted Position

Number of Participants With Improved Image Quality in the Shifted Position

Adaptive Applicator in the Standard Position

Adaptive Applicator in the Shifted Position

Single Arm-Study

The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.

Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position

3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer

Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".

Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing

Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.

Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.

Anti-Infective Agents

Carbamide Peroxide

This is a dose escalation study of IMRT for women with locally advanced cervical cancer. Three dose levels will be investigated, (although, the first dose level is considered to be the equivalent to a standard pelvic dose with parametrial boost). Before moving to the next dose level it must be confirmed by the Chief Investigator that the Maximum Administrable Dose (MAD) has not been met in the previous dose level (see section 6.3). If MAD is reached before dose level 3 the study will stop. All patients enrolled on the study will undergo the same procedures at the same time points, regardless of the dose level they are being given (see section 5).

Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment. Again this is standard treatment for any patient with cervix cancer.

Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy). This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study. As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis. This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28. Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 15 minutes. This is exactly the same as standard practice if patients were not participating in the trial.

Intensity-modulated radiation therapy

Intracavitary brachytherapy Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six. This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes.

Melanie Powell

This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.

Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer

A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer

Barts & The London NHS Trust

Paclitaxel

Albumin-Bound Paclitaxel

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

Pelvic 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.

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

Peking University First Hospital

Cangzhou Central Hospital

The Second Affiliated Hospital of Dalian Medical University

Tumor Hospital of Gansu

First Affiliated Hospital of Guangxi Medical University

Harbin Medical University Third Affiliated Hospital

Wuhan Union Hospital, China

First Affiliated Hospital of Chongqing Medical University

Guizhou Provincial People's Hospital

Second Hospital of Jilin University

China-Japan Union Hospital, Jilin University

Jilin Provincial Tumor Hospital

Jiangsu Cancer Institute & Hospital

The 940th Hospital of Joint Logistics Support Force，PLA.

General Hospital of Benxi Iron & Steel Industry Group

The Affiliated Hospital of Inner Mongolia Medical University

General Hospital of Ningxia Medical University

Beijing Obstetrics and Gynecology Hospital

Tangshan People's Hospital

Zhongnan Hospital of Wuhan University & Second Clinical Hospital of Wuhan University

Second Affiliated Hospital of Xi'an Jiaotong University

First Affiliated Hospital Xi'an Jiaotong University

The Affiliated Tumor Hospital of Xinjiang Medical University

Zhejiang Cancer Hospital

The First Affiliated Hospital of Zhengzhou University

Affiliated Cancer Hospital of Zhengzhou University

Seventh Medical Center of PLA Army General Hospital

Shengjing Hospital

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Xiangya Hospital of Central South University

Henan Provincial People's Hospital

Xi'an Gaoxin Hospital

West China Second University Hospital

The Forth Affiliated Hospital of Guangxi Medical University

Peking Union Medical College Hospital

Vice director of Radiation Oncology Department

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma, Ductal

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

lumpectomy with accelerated partial breast irradiation

single dose in the operating room after lumpectomy

Intra-Operative Radiotherapy (IORT)

Lumpectomy

Whole Breast Radiotherapy

Intracavitary Brachytherapy

Accelerated External Beam 3-D Conformal Radiotherapy

Stereotactic APBI

Frederick M. Dirbas

To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer	NCT00012012	Cervical Cancer Radiation Toxic...	Amifostine trih... Cisplatin Intracavitary b... External beam r...	18 Years -	Radiation Therapy Oncology Group
Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study	NCT01706705	Cervical Cancer	Intracavitary A... Computed Tomogr... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer	NCT01230996	Locally Advance...	Cisplatin Intensity-modul... Intracavitary b...	18 Years - 65 Years	Barts & The London NHS Trust
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
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer	NCT00185744	Breast Cancer Carcinoma, Duct...	Intra-Operative... Lumpectomy Whole Breast Ra... Intracavitary B... Accelerated Ext... Stereotactic AP...	40 Years -	Stanford University
Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer	NCT01230996	Locally Advance...	Cisplatin Intensity-modul... Intracavitary b...	18 Years - 65 Years	Barts & The London NHS Trust
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer	NCT00185744	Breast Cancer Carcinoma, Duct...	Intra-Operative... Lumpectomy Whole Breast Ra... Intracavitary B... Accelerated Ext... Stereotactic AP...	40 Years -	Stanford University
Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study	NCT01706705	Cervical Cancer	Intracavitary A... Computed Tomogr... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for intracavitary brachytherapy