Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia

PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.


Clinical Trial Description

OBJECTIVES:

Primary

- Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator (IRC) ablation versus observation.

Secondary

- Determine the tolerability and safety of IRC ablation versus observation in these patients.

- Compare the proportion of patients with HGAIN at 1 year.

- Evaluate the response and recurrence rates at 1 year of individual lesions in patients treated with this regimen vs observation.

- Determine the incidence of metachronous lesions in these patients.

- Compare the response and recurrence rates at 2 years of individual lesions in patients under observation who subsequently received IRC ablation with the response and recurrence rates at 1 year in patients initially treated with IRC.

OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients are randomized to 1 of 2 arms.

- Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is reapplied until the level of submucosal vessels are reached.

- One week after each IRC ablation, patients complete a questionnaire regarding pain, bleeding, and other complaints.

- Arm II: Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions.

NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year).

Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01164722
Study type Interventional
Source AIDS Malignancy Consortium
Contact
Status Completed
Phase Phase 3
Start date April 2011
Completion date July 2016

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05060471 - PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients Phase 2
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Completed NCT05518201 - Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old Phase 1
Withdrawn NCT02857608 - A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Phase 2
Active, not recruiting NCT02546973 - Quality of Life in Patients With Anal Cancer
Terminated NCT00903396 - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer Phase 2
Completed NCT00550589 - Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Phase 2
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00324415 - Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Phase 2
Terminated NCT00568425 - QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
Terminated NCT00267787 - Molecular Genetic and Pathological Studies of Anal Tumors
Completed NCT00066430 - Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Phase 1
Completed NCT04083053 - High-Resolution Anoscopy Perceived Discomfort Study N/A
Completed NCT03506529 - Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Recruiting NCT04857528 - Detecting HPV DNA in Anal and Cervical Cancers
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Active, not recruiting NCT01937780 - Anal Cancer Radiotherapy Study