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NCT Number: NCT01941966

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.

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.

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Key information

Conditions

Anal Canal Cancer. Anal Canal Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICESP

São Paulo, 01246000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Mitomycins

Drug

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

Radiotherapy

Radiation

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

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.

    Time frame: 6 months of the end of radiotherapy and chemotherapy.

Secondary outcomes

  1. 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).

  2. Complete Response

    Time frame: 4 weeks after the end of the treatment

    Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.

  3. 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.

  4. 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.

  5. Colostomy rate

    Time frame: Within 1 year after the end of the treatment.

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2013
First posted
Sep 13, 2013
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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