Conservative approach in rectal cancer

Completed

• Conditions: Patients with primary local advanced rectal cancer; Cancer; Malignant neoplasm of rectum

• Registration Number: ISRCTN60597075
• Lead Sponsor: Regional Health and Social Agency (Agenzia Sanitaria e sociale Regionale- Regione Emilia Romagna) (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Patients (aged above 18) with histological proven adenocarcinoma of the distal part of the rectum (between 3 and 10 cm from anal verge)
2. T2-3 tumour without lymph nodes > 1.5 cm and/or lateral pelvic lymph nodes > 1 cm at MRI and/or endoanal ultrasound
3. Tumour size less than or equal to 5 cm
4. No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required
5. Absolute Neutrophil Count (ANC) more than 1.5 x 109/l
6. Thrombocytes > 100 x 109/l
7. Creatinin clearance >50ml/min (according to the Cockcroft-Gault formula)
8. Total serum bilirubin < 24 mol/l or below <1.5 times the upper limit of the normal
9. Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT): up to 5 times the upper limit
10. Colonoscopy or virtual colonoscopy should exclude synchronous colorectal lesions in other parts of the colon
11. Eastern Cooperative Oncology Group (ECOG) performance score 0-2
12. Fertile women should have adequate birth control during treatment
13. Mental/physical/geographical ability to undergo treatment and follow-up
14. Written informed consent (Italian language)

Exclusion Criteria

1. Preoperative staging by pelvic MRI and/or EUS of any cT1, any cT4, or cT2, N0.
2. Patients with circumferential rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra anal tumors, tumors within 3mm of mesorectal fascia).
3. Tumours which are mucinous (>50% mucin seen on MRI), as these are more likely to be PET negative.
4. Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints of soiling due to the tumor will not be an exclusion criterium).
5. Any contra-indication to MRI scanning
6. Severe uncontrollable medical or neurological disease.
7. Patients with secondary prognosis determining malignancies.
8. Patients who have been treated with radiotherapy on the pelvis.
9. Fenytoine and Allopurinol use.
10. Known DPD deficiency
11. Uncontrolled active infection,immune status, psychosis, or CNS disease.
12. Pregnant or lactating women.
13. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months prior to treatment), myocardial infarction (= 6 months prior to treatment),
14. Unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
15. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Capecitabine or patients at high risk for treatment complications.
16. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy).

Study & Design

• Study Type: Interventional
• Study Design: Not specified