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

Phase 1

Completed

• Conditions: Rectal or Anal Cancer
• Interventions: Radiation: endorectal brachytherapy; Drug: concurrent capecitabine or 5-FU; Behavioral: Questionnaires

• Registration Number: NCT02199236
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Status Verified: 2024-10
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus

• Prior pelvic EBRT

• Age > or = to 18 years

• ECOG performance status 0, 1, or 2

• At least 4 weeks from prior major surgery or radiotherapy

• Have undergone Surgical, Medical and Radiation Oncology evaluations to confirm :

  • Eligible for infusional 5-FU or capecitabine
  • Will not undergo surgery for the study disease
  • 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

• Adequate Hepatic functions: Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)

• AST or ALT <3xULN, or <5x ULN if known liver metastases

• Normal Cardiac function:

  • No active coronary artery disease;
  • No New York Heart Association class II, III or IV disease;
  • No arrhythmia requiring treatment
  • Maximum tumor length of 7 cm at time of brachytherapy treatment start

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Exclusion Criteria

• Women who are pregnant.
• 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.
• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
• Patients on concurrent anti-cancer therapy other than that allowed in the study.
• Contraindications to general anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endorectal brachytherapy, concurrent chemo and questionnaires	endorectal brachytherapy	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.
endorectal brachytherapy, concurrent chemo and questionnaires	Questionnaires	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.
endorectal brachytherapy, concurrent chemo and questionnaires	concurrent capecitabine or 5-FU	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.

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose (MTD)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
tumor response	3, 6, and 12 months	MRI with DCE \& DWI (unless contraindicated) after brachytherapy

Trial Locations

Locations (7)

Memorial Sloan Kettering Commack (Consent and Follow up); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth (Follow Up Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Follow Up Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Follow Up Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Follow-Up only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Rockville Center (Follow Up Only); 🇺🇸 Rockville Centre, New York, United States