Back to resultsA Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
Primary Purpose
Anal Canal Cancer.
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Capecitabine
Mitomycins
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Anal Canal Cancer. focused on measuring Anal canal cancer;capecitabine; mitomycin; radiotherapy.
Eligibility Criteria
Inclusion Criteria:
- Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl.
- Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) < 3 × ULN (upper limit of normal).
- Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min.
- Signed written informed consent.
Exclusion Criteria:
- Major surgical procedure within 4 weeks of the beginning of the treatment.
- History of severe systemic or psychiatric disease.
- Previous treatment for anal canal carcinoma or other cancer.
- For female patients, current pregnancy and/or lactation
- Unstable angina or acute myocardial infarction within 6 months.
- Concomitant use of oral anticoagulants
- HIV positive with result of CD4 ≤ 200.
- Previously pelvic radiotherapy.
Sites / Locations
- ICESP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemo-radiotherapy
Arm Description
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
Outcomes
Primary Outcome Measures
The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.
Secondary Outcome Measures
Treatment Toxicity
Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).
Complete Response
Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.
Overall survival
Progression-free survival
Colostomy rate
Full Information
NCT ID
NCT01941966
First Posted
September 5, 2013
Last Updated
March 26, 2014
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01941966
Brief Title
A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
Official Title
A Phase II Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
5. Study Description
Brief Summary
The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been growing recently. The standard treatment of anal cancer stage II-III is multimodal and consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy. This scheme currently used was proposed in 1974, and since then no other effective treatment has been developed.
The purpose of this study is to determine the efficacy and toxicity of the combination of capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal. For this will be selected 51 patients to be treated with chemo-radiotherapy.
The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Canal Cancer.
Keywords
Anal canal cancer;capecitabine; mitomycin; radiotherapy.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemo-radiotherapy
Arm Type
Experimental
Arm Description
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine, PO, 825mg/m2, on days: 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26, 29, 30, 31, 32, 33, 36, 37, 38, 39 and 40 of radiotherapy period.
Intervention Type
Drug
Intervention Name(s)
Mitomycins
Intervention Description
15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks
Primary Outcome Measure Information:
Title
The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.
Time Frame
6 months of the end of radiotherapy and chemotherapy.
Secondary Outcome Measure Information:
Title
Treatment Toxicity
Description
Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).
Time Frame
Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events.
Title
Complete Response
Description
Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.
Time Frame
4 weeks after the end of the treatment
Title
Overall survival
Time Frame
Every 3 months during the first year after the end of the treatment, then every 6 months in the second and third year, and after the fourth year the visit will be annual.
Title
Progression-free survival
Time Frame
A chest x-ray and computerized tomography of abdomen and pelviswill be performed after 6 weeks of the end of treatment and 6 months after.
Title
Colostomy rate
Time Frame
Within 1 year after the end of the treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl.
Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) < 3 × ULN (upper limit of normal).
Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min.
Signed written informed consent.
Exclusion Criteria:
Major surgical procedure within 4 weeks of the beginning of the treatment.
History of severe systemic or psychiatric disease.
Previous treatment for anal canal carcinoma or other cancer.
For female patients, current pregnancy and/or lactation
Unstable angina or acute myocardial infarction within 6 months.
Concomitant use of oral anticoagulants
HIV positive with result of CD4 ≤ 200.
Previously pelvic radiotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo MG Hoff, PHD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246000
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://www.icesp.org.br
Description
Related Info
Learn more about this trial
A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
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