Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
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ClinicalTrials.gov Identifier: NCT04166318 |
Recruitment Status :
Recruiting
First Posted : November 18, 2019
Last Update Posted : June 22, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 6, 2019 | ||||||
First Posted Date ICMJE | November 18, 2019 | ||||||
Last Update Posted Date | June 22, 2023 | ||||||
Actual Study Start Date ICMJE | January 2, 2020 | ||||||
Estimated Primary Completion Date | December 31, 2029 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
Overall survival [ Time Frame: Up to 5 years ] Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study | ||||||
Official Title ICMJE | A Randomized Phase II Study De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE) | ||||||
Brief Summary | 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. | ||||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
252 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2029 | ||||||
Estimated Primary Completion Date | December 31, 2029 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT04166318 | ||||||
Other Study ID Numbers ICMJE | EA2182 NCI-2019-02259 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) EA2182 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) EA2182 ( Other Identifier: CTEP ) U10CA180820 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ) | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | ECOG-ACRIN Cancer Research Group | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
Investigators ICMJE |
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PRS Account | Eastern Cooperative Oncology Group | ||||||
Verification Date | June 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |