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Trial record 35 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Anus Diseases"

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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ClinicalTrials.gov Identifier: NCT02199236
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rectal or Anal Cancer Radiation: endorectal brachytherapy Drug: concurrent capecitabine or 5-FU Behavioral: Questionnaires Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Experimental: endorectal brachytherapy, concurrent chemo and 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.
Radiation: endorectal brachytherapy
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).

Drug: concurrent capecitabine or 5-FU

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.


Behavioral: Questionnaires
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.
Other Names:
  • Bowel Function Assessment
  • Quality of Life Assessment




Primary Outcome Measures :
  1. maximum tolerated dose (MTD) [ Time Frame: 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 :
  1. tumor response [ Time Frame: 3, 6, and 12 months ]
    MRI with DCE & DWI (unless contraindicated) after brachytherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199236


Contacts
Contact: Abraham Wu, MD 212-639-5257
Contact: Phillip Paty, MD 212-639-6703

Locations
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Abraham Wu, MD    212-639-5257      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Abraham Wu, MD    212-639-5257      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Abraham Wu, MD    212-639-5257      
Memorial Sloan Kettering West Harrison Recruiting
Harrison, New York, United States, 10604
Contact: Abraham Wu, MD    212-639-5257      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Abraham Wu, MD    212-639-5257      
Contact: Phillip Paty, MD    212-639-6703      
Sub-Investigator: Abraham Wu, MD         
Memorial Sloan Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Abraham Wu, MD    212-639-5257      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Abraham Wu, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02199236     History of Changes
Other Study ID Numbers: 14-104
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
High-Dose-Rate Brachytherapy
oral capecitabine
infusional 5-FU
Questionnaires
14-104

Additional relevant MeSH terms:
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents