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.

NCT01941966 | Completed Phase 2

• 1 other identifier: NP 84/2010
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Canal Cancer.

Keywords

Anal canal cancer;capecitabine; mitomycin; radiotherapy.

Outcome Measures

Primary Outcomes (1)

• 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 months of the end of radiotherapy and chemotherapy.

Secondary Outcomes (5)

• Treatment Toxicity

  Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events.

• Complete Response

  4 weeks after the end of the treatment

• Overall survival

  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

  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

  Within 1 year after the end of the treatment.

Study Arms (1)

Chemo-radiotherapy

EXPERIMENTAL

Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy

Drug: Capecitabine; Drug: Mitomycins; Radiation: Radiotherapy

Interventions

Capecitabine DRUG

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.

Chemo-radiotherapy

Mitomycins DRUG

15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy

Chemo-radiotherapy

Radiotherapy RADIATION

Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks

Chemo-radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anal Canal Carcinoma

Interventions

Capecitabine; Mitomycins; Radiotherapy

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Paulo MG Hoff, PHD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

BR (1)