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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

Primary Purpose

Rectal or Anal Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
endorectal brachytherapy
concurrent capecitabine or 5-FU
Questionnaires
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal or Anal Cancer focused on measuring High-Dose-Rate Brachytherapy, oral capecitabine, infusional 5-FU, Questionnaires, 14-104

Eligibility Criteria

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

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

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Follow Up Only)
  • Memorial Sloan Kettering Monmouth (Follow Up Only)
  • Memorial Sloan Kettering Commack (Consent and Follow up)
  • Memorial Sloan Kettering Westchester (Follow Up Only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Center (Follow Up Only)
  • Memorial Sloan Kettering Nassau (Follow-Up only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endorectal brachytherapy, concurrent chemo and questionnaires

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

tumor response
MRI with DCE & DWI (unless contraindicated) after brachytherapy

Full Information

First Posted
July 22, 2014
Last Updated
July 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02199236
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal or Anal Cancer
Keywords
High-Dose-Rate Brachytherapy, oral capecitabine, infusional 5-FU, Questionnaires, 14-104

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endorectal brachytherapy, concurrent chemo and questionnaires
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
endorectal brachytherapy
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
concurrent capecitabine or 5-FU
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Bowel Function Assessment, Quality of Life Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
maximum tolerated dose (MTD)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
tumor response
Description
MRI with DCE & DWI (unless contraindicated) after brachytherapy
Time Frame
3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Wu, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Follow Up Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Follow Up Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent and Follow up)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Follow Up Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Center (Follow Up Only)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Follow-Up only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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