Adaptive Radiation in Anal Cancer

Trial Title: Adaptive Radiation in Anal Cancer

NCT ID: NCT05838391

Condition: Anal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Anus Neoplasms
Capecitabine
Fluorouracil
Mitomycins
Mitomycin

Conditions: Keywords:
Anal cancer
Adaptive radiation
Chemotherapy
Radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery
Description: 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.
Arm group label: Chemotherapy and Adaptive Radiation Treatment Planning

Other name: Adaptive RT Planning and Delivery

Intervention type: Drug
Intervention name: Mitomycin-C
Description: 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.
Arm group label: Chemotherapy and Adaptive Radiation Treatment Planning

Intervention type: Drug
Intervention name: 5-Fluorouracil
Description: 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.
Arm group label: Chemotherapy and Adaptive Radiation Treatment Planning

Other name: 5-FU

Intervention type: Drug
Intervention name: Capecitabine
Description: 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.
Arm group label: Chemotherapy and Adaptive Radiation Treatment Planning

Other name: Xeloda

Summary: This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.

Detailed description: The standard treatment for Human Papilloma Virus (HPV)-positive locally advanced anal cancer (described as a tumor that is greater than 4 cm in size, or with positive lymph nodes) is 54 Gy of radiation treatment to the anal canal and primary tumor planning total volume (PTV), 50.4-54 Gy to positive nodal PTV and 45 Gy to elective lymph node PTV with 5-fluorouracil (5-FU) and mitomycin-C chemotherapy administered at the same time as radiation in 30 fraction (treatments) delivery. During the six week course of radiotherapy, there is often a notable decrease in volume of the tumor (both primary and regional nodes), as early as one week into treatment, detected on weekly on-board Cone Beam Computed Tomography (CBCT), which is a scan done on the treatment machine while patients receive radiation to ensure that the tumor is being treated and normal tissue is not. However, CT simulation (a CT scan used to plan radiation treatment) and re-planning of the treatment to account for the tumor shrinkage are not routinely performed due to time, patient inconvenience and staffing resources. As such, daily adaptive radiation, which can generate a new CT-based plan using the anatomy of the day, may be a time efficient method to both plan and treat the patient.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Columbia University Irving Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Mariamne Reyna

Phone: 646-317-4244
Email: mo2213@cumc.columbia.edu

Investigator:
Last name: Lisa Kachnic, MD
Email: Principal Investigator

Investigator:
Last name: David Horowitz, MD
Email: Sub-Investigator

Start date: May 18, 2023

Completion date: December 31, 2028

Lead sponsor:
Agency: Columbia University
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: Columbia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05838391