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

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Fluorouracil

Capecitabine

Mitomycins

Mitomycin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

Intensity-Modulated Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Site Public Contact

Alison K. Conlin

Nicholas DiBella

John A. Ellerton

Shahzad Siddique

Jay W. Carlson

James D. Murphy

Jason A. Zell

Tyler Robin

Gregory A. Masters

Anteneh A. Tesfaye

Lorraine Portelance

Michael D. Chuong

Patrick Kelly

Sudha R. Amarnath

John M. Schallenkamp

Daniel H. Barnett

Bryan A. Faller

Sheetal M. Kircher

Thomas Kim

Yolande Chen

Jennifer A Dorth

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

PRIMARY OBJECTIVES:

I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose chemoradiation therapy (CRT), as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year.

SECONDARY OBJECTIVES:

I. To compare changes in patient-reported outcomes (as per Fecal Incontinence Severity Index \[FISI\], Patient Reported Outcomes Measurement Information System \[PROMIS\], International Index of Erectile Function \[IIEF\], Sexual Function-Vaginal Changes Questionnaire \[SVQ\], and Vaginal Assessment Scale \[VAS\]/Vulvar Assessment Scale \[VuAS\] instruments) between the experimental and control arm.

II. To compare patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation), disease control, and overall survival between experimental and control arm.

III. To correlate vaginal dilator use during radiation delivery with sexual function.

IV. To measure changes in serum total testosterone from baseline to up to 12 months after radiation.

V. To validate the utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemoradiation is appropriate.

VI. To determine whether an online, interactive educational tool (eContour) may improve the quality of radiation target delineation for anal cancer.

VII. To determine the incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil (5-FU) or capecitabine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (STANDARD-DOSE CHEMORADIATION): Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin intravenously (IV) over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine orally (PO) twice daily (BID) 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

ARM B (DE-INTENSIFIED CHEMORADIATION): Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

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, then annually for years 4-5.

Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study

A Randomized Phase II Study De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).

An event is local-regional failure, distant metastasis and chemoradiation-related death. Will determine if de-intensified chemoradiation achieves 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose CRT, as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. The co-primary endpoints of disease control and FIQoL will be formally assessed in a hierarchical manner with disease control being assessed first. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).

Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.

Will compare changes as per HRQL: Health Related Quality of Life FACT-G (Functional Assessment of Cancer Therapy-General - Scoring: 0 - 32 with higher worse) between the experimental and control arm. Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.

Will compare changes as per Fecal Incontinence Severity Index \[FISI - Scoring: 0 - 61 with lower better\] between the experimental and control arm.

Will compare changes as per International Index of Erectile Function \[IIEF\], Erectile Dysfunction: Scoring 7 - 35 with lower better. Ejaculation Frequency: Scoring 1 - 5 with lower better - between the experimental and control arm.

Will compare changes as per Orgasm ability/pleasure (PROMIS-Brief): scoring 2 - 10 with lower better - between the experimental and control arm.

PROMIS = Patient Reported Outcomes Measurement Information System

Will compare changes as per Anal Discomfort/pain (PROMIS- Full): scoring 3 - 15 with lower better. - between the experimental and control arm.

PROMIS = Patient Reported Outcomes Measurement Information System

Will compare changes as per Satisfaction with sex life (PROMIS-Brief) (scoring 2 - 10 with higher better) between the experimental and control arm.

PROMIS = Patient Reported Outcomes Measurement Information System

Will compare changes as per Therapeutic Aids for Sexual Function - Male (Scoring 6 - 22 with lower better) between the experimental and control arm.

Will compare changes as per Therapeutic Aids for Sexual Function - Female (Scoring 5 - 17 with lower better) between the experimental and control arm.

Will compare changes as per Sexual Function-Vaginal Changes Questionnaire \[SVQ\] (Scoring 5 - 26 with higher better) between the experimental and control arm.

Will compare changes as per Vaginal Assessment Scale \[VAS\]/Vulvar Assessment Scale \[VuAS\] (Scoring:0 - 22 with lower better) between the experimental and control arm.

Will be compared between experimental and control arm. The cumulative incidence method will be used to estimate local-regional and distant failure rates and the failure rates for the experimental treatment will be compared against the control using a failure specific log rank test.

Vaginal dilator use during radiation delivery will be correlated with sexual function.

Will be validated as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified CRT is appropriate.

Will determine whether an online, interactive educational tool (eContour) may improve the quality of radiation target delineation for anal cancer.

Rates of grade 3+ adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v.\] 5) will be estimated using a binomial distribution along with their associated 95% confidence intervals and compared using Fisher's exact test between arms.

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
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study	NCT04166318	Anal Basaloid C... Anal Canal Cloa... Anal Canal Squa... Anal Margin Squ... Stage I Anal Ca... Stage IIA Anal ...	Capecitabine Fluorouracil Intensity-Modul... Mitomycin Quality-of-Life... Questionnaire A...	18 Years -	Eastern Cooperative Oncology Group

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