Adaptive Radiation in Anal Cancer
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ClinicalTrials.gov Identifier: NCT05838391 |
Recruitment Status :
Recruiting
First Posted : May 1, 2023
Last Update Posted : July 13, 2023
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Condition or disease | Intervention/treatment | Phase |
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Anal Squamous Cell Carcinoma | Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery Drug: Mitomycin-C Drug: 5-Fluorouracil Drug: Capecitabine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma |
Actual Study Start Date : | May 18, 2023 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2028 |
Arm | Intervention/treatment |
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Experimental: Chemotherapy and Adaptive Radiation Treatment Planning
Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).
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Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery
Subjects will receive 54 Gy of radiation delivered 5 day a week for 6 weeks, 30 radiation treatments total. Intensity-Modulated photon radiation therapy will be delivered on a Varian Ethos linear accelerator. Daily image-guided radiation therapy (IGRT) is required. All treatments will have artificial-intelligence (AI) daily adaptations of the radiation plan to optimize the radiation dose to the targeted area and minimize radiation dose to the normal surrounding organs such as the bowel.
Other Name: Adaptive RT Planning and Delivery Drug: Mitomycin-C As part of the subjects' treatment, 10 mg/meters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29. Drug: 5-Fluorouracil As part of the subjects' treatment, 1g/meters squared/day for 4 days of 5-Fluorouracil will be administered by continuous infusion on Days 1-4 (for 96 hours) and Days 29-32 (for 96 hours). 5-Fluorouracil or capecitabine will be administered per the physician's discretion.
Other Name: 5-FU Drug: Capecitabine As part of the subjects' treatment, 825 mg/meters squared per day, divided into 2 daily doses, will be taken on days of radiotherapy. Capecitabine or 5-FU will be administered per the physician's discretion.
Other Name: Xeloda |
- Time to plan and deliver treatment fractions. [ Time Frame: Up to 6 weeks ]This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.
- Acute Treatment Toxicity [ Time Frame: Up to 1 month post-treatment ]Toxicity of treatment will be analyzed using NCI-CTCAE v5.0.
- Complete Clinical Response Rate [ Time Frame: 6 months following the completion of chemoradiation ]Complete response to treatment (CR) is defined as absence of detectable cancer.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.
- American Joint Committee on Cancer (AJCC) 8th edition stage T2 > 4 cm, T3-4 or N1.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
- Life expectancy of greater than 12 months.
- Patients must have normal organ and marrow function as defined below:
- leukocytes greater than or equal to 3,000/microliter
- absolute neutrophil count greater than or equal to 1,500/microliter
- platelets greater than or equal to 100,000/microliter
- total bilirubin within normal institutional limits
- Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.
- Prior chemotherapy or radiation for anal cancer.
- Patients who have undergone complete surgical resection.
- Presence of recurrent/metastatic disease.
- Prior allergic reaction to 5-Fluorouracil or mitomycin C.
- Artificial organ prosthetics, pacemakers or other implantable devices.
- Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.
- Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease.
- Women who are pregnant or lactating.
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): NCT05838391
Contact: Mariamne Reyna | 646-317-4244 | mo2213@cumc.columbia.edu |
United States, New York | |
Columbia University Irving Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Mariamne Reyna 646-317-4244 mo2213@cumc.columbia.edu | |
Principal Investigator: Lisa Kachnic, MD | |
Sub-Investigator: David Horowitz, MD |
Principal Investigator: | Lisa Kachnic, MD | Principal Investigator |
Responsible Party: | Lisa A. Kachnic, Chu H. Chang Professor of Radiation Oncology; Chair, Department of Radiation Oncology, Columbia University |
ClinicalTrials.gov Identifier: | NCT05838391 |
Other Study ID Numbers: |
AAAU0074 |
First Posted: | May 1, 2023 Key Record Dates |
Last Update Posted: | July 13, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Anal cancer Adaptive radiation Chemotherapy Radiotherapy |
Carcinoma Carcinoma, Squamous Cell Anus Neoplasms Neoplasms, Squamous Cell Anus Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Capecitabine Fluorouracil Mitomycins Mitomycin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic |