A Phase I, Dose Escalation Trial of Endoluminal High Dose Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management
Sponsor study identifier
interventional
15
1 country
7
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 29, 2024
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 22, 2014
Actual (reported)July 24, 2014
Actual (reported)October 29, 2024
Actual (reported)October 29, 2024
Actual (reported)maximum tolerated dose (MTD)
will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3. An initial cohort of 3 patients will be treated to each dose. The dose level will be escalated if none of the 3 patients exhibits any DLT within 90 days of completion of brachytherapy. Dose escalation will not take place until every patient in the prior dose cohort has been monitored for 90 days.
1 year
tumor response
3, 6, and 12 months
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.
Patients will receive 3 fractions of endorectal brachytherapy, each spaced apart by 7 days (+/- 1 day). The three dose tiers will be 1500cGy (500cGy per fraction), 1800cGy (600cGy per fraction), and 2100cGy (700cGy per fraction).
Patients will receive 500 mg and 150 mg oral tablets of capecitabine for the prescribed dose of 825 mg/m2 BID, morning and evening (total daily dose of 1650 mg/m2 ). Dosages will be rounded to the nearest 150 mg or 500 mg. Tablets should be swallowed with water within 30 minutes after a meal. Capecitabine will be started on the Monday of the first week of brachytherapy (day 1) and taken on weekdays (Monday through Friday) during weeks of brachytherapy only. Administration of 5-FU should be only by the intravenous route taking care to avoid extravasation. Patients will receive 225 mg/m2/day, as a continuous venous infusion by a portable pump for the 3 weeks of treatment. The infusional 5-FU will be exchanged every 7 days.
Memorial Sloan Kettering Basking Ridge (Follow Up Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Follow Up Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Follow Up Only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Center (Follow Up Only)
Rockville Centre, New York, 11570, United States
Abraham Wu, MD
Memorial Sloan Kettering Cancer Center
15 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2014
First Posted
July 24, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Patients should complete the 2 quality of life questionnaires during their follow-up appointments. If they are unable to be seen in follow-up, they may complete the questionnaires at home and email or mail them back to the investigator. Should there be any incomplete or ambiguous answers, a follow-up phone call will be made by a member of the research team for clarification. Additionally, if the questionnaires have not been returned within 3 weeks after the time when they are due, a member of the research team will call the patient, and the questions will be completed over the phone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Memorial Sloan Kettering Nassau (Follow-Up only)
Uniondale, New York, 11553, United States
Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)Last Updated
November 1, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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