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Chemotherapy

Brachytherapy + Chemotherapy for Rectal or Anal Cancer

Phase 1
Waitlist Available
Led By Abraham Wu, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to receive HDR brachytherapy ANC ≥ 1.5 cells/mm3 and PLT ≥100,000/mm3
Adequate Renal function: Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50cc/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing how much radiation is safe to give to anal/rectal cancer patients during brachytherapy treatment.

Who is the study for?
This trial is for adults over 18 with confirmed rectal or anal cancer that's come back or isn't being removed by surgery. They must have had prior radiation, be in decent health (ECOG 0-2), and have good liver, kidney, and heart function. Pregnant women can't join, and participants must agree to avoid pregnancy.Check my eligibility
What is being tested?
The study tests how much radiation can safely be given using brachytherapy alongside chemotherapy drugs capecitabine or 5-FU for treating recurrent rectal or anal cancer. It also involves filling out questionnaires about the treatment experience.See study design
What are the potential side effects?
Possible side effects include those from high-dose radiation like skin irritation, fatigue, bowel issues; from chemotherapy such as nausea, mouth sores; and general risks of anesthesia during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a specific radiation therapy with enough white blood cells and platelets.
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My kidney function is within the normal range.
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My heart is healthy with no severe disease or arrhythmias, and my tumor is no larger than 7 cm.
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My cancer in the rectum or anus has been confirmed by a lab test.
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I am 18 years old or older.
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I will not have surgery for my condition as part of this study.
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I can take care of myself and am up and about more than half of my waking hours.
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I have had radiation therapy to my pelvis before.
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I can receive chemotherapy through an IV or as a pill.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
maximum tolerated dose (MTD)
Secondary outcome measures
tumor response

Trial Design

1Treatment groups
Experimental Treatment
Group I: endorectal brachytherapy, concurrent chemo and questionnairesExperimental Treatment3 Interventions
This is a phase I, dose-escalation study to evaluate the safety of endorectal brachytherapy with concurrent capecitabine or 5-fluoruracil (5-FU) in the management of locally recurrent/residual rectal or anal cancer in patients who have received pelvic external beam radiation therapy (EBRT) +/- chemotherapy. We will use magnetic resonance imaging (MRI) with dynamic contrast enhancement (DCE) and diffusion weighted imaging (DWI) series to contribute to the assessment of tumor response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3030

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,792 Total Patients Enrolled
Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

Capecitabine or 5-FU (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02199236 — Phase 1
Rectal or Anal Cancer Research Study Groups: endorectal brachytherapy, concurrent chemo and questionnaires
Rectal or Anal Cancer Clinical Trial 2023: Capecitabine or 5-FU Highlights & Side Effects. Trial Name: NCT02199236 — Phase 1
Capecitabine or 5-FU (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02199236 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to sign up for this clinical experiment?

"According to clinicaltrials.gov, this medical trial has ceased recruitment as of June 13th 2022, despite having been first posted on July 1st 2014. Fortunately, there are presently 393 alternative trials recruiting volunteers at the moment."

Answered by AI

Has the FDA given authorization to administer endorectal brachytherapy?

"The safety of endorectal brachytherapy has been evaluated and given a rating of 1, as it is currently in its Phase 1 trial stage. This indicates that data supporting both efficacy and safety are limited."

Answered by AI

Have any other experiments been conducted with endorectal brachytherapy as a focus?

"Endorectal brachytherapy was initially studied in 2005 at Withington Hospital, with a total of 721 completed studies since then. Currently, 334 trials are enrolling patients and many of these interventions are taking place in Rockville Centre, NY."

Answered by AI

To what extent has the trial been populated by participants?

"At this juncture, participants are not being sought for the trial. It was initially posted on July 1st 2014 and recently revised as of June 13th 2022. Fortunately, there are currently 59 studies recruiting for anal cancer patients and another 334 related to endorectal brachytherapy that require enrolment."

Answered by AI

How many sites within the state are hosting this empirical exploration?

"Presently, this trial is running at 7 locations including Rockville Centre, Uniondale and Harrison. It may be beneficial to choose the medical centre closest you in order to streamline travelling needs if you choose to participate."

Answered by AI

To what treatments is endorectal brachytherapy typically employed?

"Endorectal brachytherapy can be employed to combat the growth of malignant neoplasms, pancreatic endocrine carcinomas, and colorectal carcinoma."

Answered by AI
~0 spots leftby Jul 2024