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:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01941966
First received: September 5, 2013
Last updated: March 26, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Colostomy rate [ Time Frame: Within 1 year after the end of the treatment. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01941966     History of Changes
Other Study ID Numbers: NP 84/2010
Study First Received: September 5, 2013
Last Updated: March 26, 2014
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Anus Neoplasms
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
Mitomycins
Mitomycin
Capecitabine
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on July 24, 2014