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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01941966
First Posted: September 13, 2013
Last Update Posted: March 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
  Purpose

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.


Condition Intervention Phase
Anal Canal Cancer. Drug: Capecitabine Drug: Mitomycins Radiation: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

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. [ Time Frame: 6 months of the end of radiotherapy and chemotherapy. ]

Secondary Outcome Measures:
  • Treatment Toxicity [ Time Frame: Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events. ]
    Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).

  • Complete Response [ Time Frame: 4 weeks after the end of the treatment ]
    Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.

  • 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. ]
  • 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. ]
  • Colostomy rate [ Time Frame: Within 1 year after the end of the treatment. ]

Estimated Enrollment: 51
Study Start Date: November 2010
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo-radiotherapy
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
Drug: Capecitabine
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.
Drug: Mitomycins
15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy
Radiation: Radiotherapy
Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941966


Locations
Brazil
ICESP
Sao Paulo, SP, Brazil, 01246000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Principal Investigator: Paulo MG Hoff, PHD Instituto do Cancer do Estado de São Paulo
  More Information

Additional Information:
Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01941966     History of Changes
Other Study ID Numbers: NP 84/2010
First Submitted: September 5, 2013
First Posted: September 13, 2013
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Anal canal cancer;capecitabine; mitomycin; radiotherapy.

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Anus Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic