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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

Must not have

Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy. Male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy

Women who are pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using or willing to use birth control during and up to one year after treatment.

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I am currently pregnant.

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I cannot have general anesthesia due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum tolerated dose (MTD)

Secondary study objectives

tumor response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

concurrent capecitabine or 5-FU

2014

Completed Phase 1

~20

Questionnaires

2013

Completed Phase 2

~4280