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A Study of Patients Receiving High-Dose Rate Brachytherapy

Primary Purpose

Cervical Cancer, Endometrial Cancer, Esophageal Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HDR Brachytherapy

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Radiation, Cancer, HDR, Brachytherapy, Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:
1. Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen.
2. Age greater than 18 years of age.
3. ECOG performance status of 0, 1, or 2.
4. Participant must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the participant.
5. Participants of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
6. Site-specific inclusion criteria (any one or more of the following):

Gynecologic Cancers:

Endometrial cancer

Participants at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)
Participants who have suffered a recurrence at the vaginal cuff
Participants who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer.

Cervical cancer

Participants who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer.
Participants with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting).

Lung cancer

Participants with an endobronchial component causing symptoms
Participants who can not undergo resection because of poor lung function or distant lung metastasis

Breast cancer

Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0,
Participants benefiting from HDR as either as a boost or accelerated partial breast irradiation regimen.

Prostate Cancer

-Participants with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management.

EXCLUSION CRITERIA:

Cognitively impaired participants who cannot give informed consent.
Participants currently receiving concurrent investigational chemotherapeutic agents.
Participants receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen)
Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the participant s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.
Abnormal bleeding times or active anti-coagulation therapy.
- platelets less than 100,000 per mm(3)
- PT/PTT greater than 1.5 the upper normal limit (UNL)
Any participant or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per ABS guidelines.
Participants whose malignancy has one or more of the following site-specific criteria disqualifying them from the study:

1. Breast cancer:

Participants inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);
male participants with breast cancer
autoimmune disorders, including SLE, Scleroderma, etc
distant metastases;
2. Prostate cancer:
distant metastases
lymph node metastases

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1/Radiation Therapy

Arm Description

Radiation therapy given as HDR Brachytherapy.

Outcomes

Primary Outcome Measures

To determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dos...

An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met.

Secondary Outcome Measures

To increase the flow of oncology patients requiring brachytherapy to the NCI ROB, as these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, ...

To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB

Full Information

NCT ID

NCT00924027

First Posted

June 17, 2009

Last Updated

October 19, 2023

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00924027

Brief Title

A Study of Patients Receiving High-Dose Rate Brachytherapy

Official Title

A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

Study Type

Interventional

2. Study Status

Record Verification Date

September 26, 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 14, 2009 (Actual)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

Background: One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: To evaluate the quality of the brachytherapy procedure at the National Institutes of Health s Radiation Oncology Branch. Eligibility: Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. Each treatment will take place in the Radiation Oncology Clinic. If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at baseline to evaluate the tumor response.

Detailed Description

BACKGROUND: High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms. OBJECTIVES: The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met. To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB To increase the flow of oncology participants requiring brachytherapy to the NCI ROB, as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians. ELIGIBILITY: -Participants with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment. DESIGN: Participants will undergo appropriate work-up and clinical evaluation to determine if high-dose brachytherapy would be beneficial in either primary treatment or palliation of their disease. Participants will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines. The participant s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer, Biliary Cancer

Keywords

Radiation, Cancer, HDR, Brachytherapy, Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1/Radiation Therapy

Arm Type

Experimental

Arm Description

Radiation therapy given as HDR Brachytherapy.

Intervention Type

Radiation

Intervention Name(s)

HDR Brachytherapy

Intervention Description

Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.

Primary Outcome Measure Information:

Title

Description

Time Frame

completion of treatment

Secondary Outcome Measure Information:

Title

Time Frame

completion of study

Title

To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB

Time Frame

completion of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen. Age greater than 18 years of age. ECOG performance status of 0, 1, or 2. Participant must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the participant. Participants of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. Site-specific inclusion criteria (any one or more of the following): Gynecologic Cancers: Endometrial cancer Participants at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging) Participants who have suffered a recurrence at the vaginal cuff Participants who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer. Cervical cancer Participants who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer. Participants with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting). Lung cancer Participants with an endobronchial component causing symptoms Participants who can not undergo resection because of poor lung function or distant lung metastasis Breast cancer Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0, Participants benefiting from HDR as either as a boost or accelerated partial breast irradiation regimen. Prostate Cancer -Participants with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management. EXCLUSION CRITERIA: Cognitively impaired participants who cannot give informed consent. Participants currently receiving concurrent investigational chemotherapeutic agents. Participants receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen) Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the participant s ability to tolerate this therapy or are likely to interfere with the study procedures or results. Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment. Abnormal bleeding times or active anti-coagulation therapy. platelets less than 100,000 per mm(3) PT/PTT greater than 1.5 the upper normal limit (UNL) Any participant or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per ABS guidelines. Participants whose malignancy has one or more of the following site-specific criteria disqualifying them from the study: 1. Breast cancer: Participants inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins); male participants with breast cancer autoimmune disorders, including SLE, Scleroderma, etc distant metastases; 2. Prostate cancer: distant metastases lymph node metastases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Debbie Nathan, R.N.

Phone

(301) 451-8968

dnathan@mail.nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Deborah E Citrin, M.D.

Phone

(240) 760-6206

citrind@mail.nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah E Citrin, M.D.

Organizational Affiliation

National Cancer Institute (NCI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Citations:

PubMed Identifier

10791524

Citation

Creutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11. doi: 10.1016/s0140-6736(00)02139-5.

Results Reference

background

PubMed Identifier

15940068

Citation

Kocak Z, Ozkan H, Adli M, Garipagaoglu M, Kurtman C, Cakmak A. Intraluminal brachytherapy with metallic stenting in the palliative treatment of malignant obstruction of the bile duct. Radiat Med. 2005 May;23(3):200-7.

Results Reference

background

PubMed Identifier

7635767

Citation

Perez CA, Grigsby PW, Castro-Vita H, Lockett MA. Carcinoma of the uterine cervix. I. Impact of prolongation of overall treatment time and timing of brachytherapy on outcome of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1275-88. doi: 10.1016/0360-3016(95)00220-S.

Results Reference

background

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2009-C-0100.html

Description

NIH Clinical Center Detailed Web Page

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A Study of Patients Receiving High-Dose Rate Brachytherapy

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