Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

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

The patient will receive Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy.

Whole pelvis radiation therapy will be delivered according to institutional standard of care.

SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning.

Radiation Therapy

Loren Mell, MD

The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.

This is a Phase II, single-center, single-arm, study of Stereotactic Body Radiotherapy boost for stage IB-IVB cervical cancer.

The primary objective of the study is to test the hypothesis that stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

Study participants will be recruited within the UCSD Health System. For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study. The investigator will approach the subject and offer participation in the trial. If the patient chooses to participate, they will undergo pretreatment evaluations to determine if they are a good candidate to participate further in the study. Depending on when the patient last had these tests and procedures performed, some of them may not need to be repeated.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled subject will receive radiation therapy consisting of 30 to 35 treatments. The patient will first undergo Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks, followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy. Concurrent chemotherapy may be given with radiation therapy according to the discretion of the treating oncology team. No chemotherapy will be given during the SBRT phase of treatment. During radiation therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and evaluations for stress, anxiety, and pain.

Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer

To quantify treatment-related symptoms of post traumatic stress to determine if stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT.

To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30).

To measure health-related quality of life based on the cervical cancer module (CX24).

To quantify intrafraction cervical motion using cone beam computed tomography.

University of California, San Diego

Associate Professor

Symptoms and General Pathology

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Patients with cervical cancer eligible for surgery, stage IA1 to IB2

Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.

Blood samples

Gauthier Rathat, MD

Martha Duraes, MD

Martha DURAES, MD

Gauthier RATHAT, MD

Sarah FRANCINI, MD

Pierre-Emmanuel COLOMBO, MD PhD

Pierre Emmanuel COLOMBO, MD PhD

Anne MOURREGOT, MD

Catherine FERRER, MD

Nathalie RUMEAU, CRA

Catherine MARSOLIER FERRER, MD

Renaud DE TAYRAC, MD PhD

Florent MASIA, MD

Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.

The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.

Despite recommendations for coelioscopic treatment of \< 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.

Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.

This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery	NCT04770090	Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Blood samples	18 Years -	University Hospital, Montpellier
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for cervical cancer stage ib2