Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years.

Computed Tomography

Electronic Health Record Review

Follow-Up

Positron Emission Tomography

Benny Johnson

This study determines whether a positron emission tomography (PET)/computed tomography (CT) 4-point scoring system may predict overall survival for anal squamous cell cancer patients. A 4-point scoring system involving imaging scans may help to predict how patients with anal squamous cell cancer respond to chemoradiation therapy.

PRIMARY OBJECTIVE:

I. To determine whether a PET/CT scoring system in invasive biopsy proven anal squamous cell carcinoma (SCCA) to be treated with chemoradiation with curative intent (any T any N) predicts for overall survival (OS).

SECONDARY OBJECTIVES:

I. To determine whether a PET/CT scoring system in invasive biopsy proven SCCA to be treated with definitive chemoradiation with curative intent predicts for progression free survival (PFS).

II. To determine and validate inter-reader reliability. III. To calculate C-index to evaluate the prognostic capacity of PET/CT scores for survival.

IV. To determine the association between pre-treatment PET/CT scores after treatment and OS.

EXPLORATORY OBJECTIVE:

I. To correlate level of standardized uptake value (SUV) pre and post therapy and its correlation with overall survival.

OUTLINE:

Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years.

4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer

The Role of a 4-point Therapy Response Score With PET/CT Post Definitive Chemoradiation for Anal Squamous Cell Cancer: A Prospective Study

The Kaplan-Meier method will be used. Log rank test will be used to compare OS between positron emission tomography (PET)/computed tomography (CT) negative and positive tumor group. Multivariable Cox proportional hazards models will be fitted to evaluate the association between OS and PET/CT scores, adjusting for the effects of covariates. In addition to positive and negative tumor groups, PET/CT scores of 4 categories will also be analyzed. C-index will be calculated to evaluate the prognostic capacity of PET/CT score with survival outcomes. Additionally, the Cohen kappa coefficient will be calculated to measure inter-reader agreement.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Nivolumab

Fluorouracil

Capecitabine

Mitomycins

Mitomycin

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients receive mitomycin IV on day 1 and either fluorouracil IV on day 1 or capecitabine PO BID on Monday-Friday until the completion of radiation therapy at the discretion of the treating physician. Patients also undergo IMRT QD for 20-23 treatment sessions over 6 weeks.

Intensity-Modulated Radiation Therapy

Site Public Contact

Chia-Ching (Jackie) Wang

Sharad Goyal

Julian Sanchez

Yolande Chen

Lee Ratner

Rafi Kabarriti

Celina S. Ang

Patricia A. Locantore-Ford

This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.

PRIMARY OBJECTIVES:

I. To determine the safety of reduced intensity chemo-radiation therapy (CRT) in low-risk disease.

II. To determine the safety of nivolumab after standard CRT in high-risk disease.

SECONDARY OBJECTIVES:

I. To estimate the efficacy (2-year disease-control rate \[DCR\]) of reduced intensity CRT in low risk disease.

II. To estimate the efficacy (2-year disease-free survival \[DFS\] rate) of nivolumab after standard CRT in high risk disease.

III. To evaluate the effect of low-dose CRT on immune function (CD4+ cell count) and human immunodeficiency virus (HIV) viral load.

IV. To evaluate the effect of nivolumab on immune function (CD4+ cell count) and HIV viral load.

V. To assess combination antiretroviral therapy (cART) adherence before, during, and after treatment with CRT and nivolumab to identify potential barriers to cART adherence when receiving concurrent oncological care.

EXPLORATORY OBJECTIVES:

I. To determine the human papillomavirus (HPV) genotype in primary tumor and explore the relationship between specific HPV subtypes and clinical response to reduced intensity CRT or nivolumab.

II. To explore the relationship between expression of PD-1 in immune cells and PD-L1 in immune cells or cancer epithelial cells in the primary diagnostic tumor and clinical response to nivolumab or reduced intensity CRT.

III. To describe the effects of reduced intensity CRT and nivolumab on viral HIV reservoirs.

IV. To identify the presence of cell-free plasma HPV deoxyribonucleic acid (DNA) before and after reduced intensity CRT and nivolumab and explore the relationship with clinical response.

V. To describe the effect of reduced intensity CRT on quality of life (QOL).

OUTLINE: Patients are assigned to 1 of 2 stratum.

HIGH-RISK STRATUM: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

LOW-RISK STRATUM: Patients receive mitomycin IV on day 1 and either fluorouracil IV on day 1 or capecitabine orally (PO) twice daily (BID) on Monday-Friday until the completion of radiation therapy at the discretion of the treating physician. Patients also undergo intensity modulated radiation therapy (IMRT) once daily (QD) for 20-23 treatment sessions over 6 weeks.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for years 1-2, every 6 months for year 3, and then annually for years 4-5.

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Risk-Adapted Therapy for HIV-Associated Anal Cancer

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Will be presented using descriptive statistics (with no inferential statistics involved).

Relationship with clinical response with be explored. Will be presented using descriptive statistics (with no inferential statistics involved).

Evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The adverse events will be summarized by overall, as well as by grade using frequency (percentage). A two-sided 95% confidence interval will be reported together with percentage estimates. The proportion of participants who experience grade 3-4 toxicities will be estimated using a binomial point estimate and its 95% confidence interval.

Evaluated by CTCAE version 5.0. The adverse events will be summarized by overall, as well as by grade using frequency (percentage). A two-sided 95% confidence interval will be reported together with percentage estimates. The proportion of participants who experience grade 3-4 toxicities will be estimated using a binomial point estimate and its 95% confidence interval.

Will be estimated using Kaplan-Meier method. The 95% confidence interval will be estimated using Greenwood's formula. The cumulative incidence of pelvic disease relapse will also be estimated from Kaplan-Meier method and the corresponding 90% confidence interval will be estimated using Greenwood's formula. In the analyses above, a two-sided p-value of 0.05 will be used to assess statistical significance.

Will be assessed by evaluating the changes from baseline in CD4+ using the Wilcoxon signed rank test to allow for nonnormality.

Will be assessed by evaluating the changes from baseline in HIV viral load using the Wilcoxon signed rank test to allow for nonnormality.

To assess cART adherence before, during, and after treatment with CRT and nivolumab to identify potential barriers to cART adherence when receiving concurrent oncological care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer	NCT05130073	Anal Squamous C... Stage 0 Anal Ca... Stage I Anal Ca... Stage II Anal C... Stage IIA Anal ... Stage IIB Anal ... Stage III Anal ... Stage IIIA Anal... Stage IIIB Anal... Stage IIIC Anal...	Computed Tomogr... Electronic Heal... Follow-Up Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer	NCT05130073	Anal Squamous C... Stage 0 Anal Ca... Stage I Anal Ca... Stage II Anal C... Stage IIA Anal ... Stage IIB Anal ... Stage III Anal ... Stage IIIA Anal... Stage IIIB Anal... Stage IIIC Anal...	Computed Tomogr... Electronic Heal... Follow-Up Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer	NCT04929028	AIDS-Related An... Anal Basaloid S... Anal Canal Cloa... Anal Margin Squ... Anal Squamous C... HIV Infection Rectal Squamous... Stage I Anal Ca... Stage II Anal C... Stage II Rectal... Stage III Anal ... Stage III Recta...	Capecitabine Fluorouracil Intensity-Modul... Mitomycin Nivolumab	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage ii anal cancer ajcc v8