Simultaneous Integrated Boost Radiation Therapy with concomitant Capecitabine and Mitomycin-C chemotherapy for locally advanced Anal Carcinoma

Conditions: Anal carcinoma
cancer of the anus
10002112
10017991

Registration Number: NL-OMON31876

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Patients with histologically or cytologically confirmed primary advanced anal carcinoma with tumor (T), nodal (N) and metastases (M) stage:
- T2 (>4 cm) - T3 - T4 / N0 - 1 / M0
- T1 - 4 / N2 - 3 / M0
2. Previous (neo)adjuvant chemotherapy > 12 months ago is allowed. Otherwise patients should be chemonaive.
3. Measurable or evaluable non-measurable disease
4. Age 18 years or older
5. Able to swallow and retain oral medication
6. Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis
7. Life expectancy of at least 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
8. Minimal acceptable safety laboratory values defined as:
a) ANC >= 1.5 x 10**9/L
b) Platelet count >= 100 x 10**9/L
c) Haemoglobin level >= 6.0 mmol/l or higher - prior transfusion is permitted
d) Hepatic function as defined by serum bilirubin 1.5 x ULN or less, ALT and AST and alkaline phosphatase 2.5 x ULN or less
e) Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
9. Able and willing to give written informed consent
10. WHO performance status of 0 - 2

Exclusion Criteria

1. Known CNS or leptomeningeal metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases)
2. History of another metastasized cancer less than 5 years ago
3. Uncontrolled infectious disease or known hepatitis B or hepatitis C patients
4. HIV patients treated with HAART
5. Previous radiotherapy to the pelvic and/or unguinal region
6. Uncontrolled cardiovascular disease
7. Previous severe fluoropyrimidine toxicity
8. DPYD*2A mutation present
9. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
10. Women who are pregnant or breast feeding
11. Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study
12. Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessment of the MTD and DLT of SIBRT in combination with capecitabine in<br /><br>mitomycine-C for the treatment of locally advanced anal carcinoma. </p><br>

Secondary Outcome Measures