Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers.
- Conditions
- Rectal cancer100179901001799110017998
- Registration Number
- NL-OMON50184
- Lead Sponsor
- Amsterdam UMC, locatie VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 302
1. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM,
EMR/ESD/endoscopic intramuscular dissection or polypectomy) of an early rectal
cancer without carcinoma in the resection plane.
2. Patients without carcinoma in the resection plane or in case of unreliable
resection planes (EMR/ESD) no macroscopic residual tumour confirmed by
endoscopy are eligible for randomisation.
3. Only lesions for which TME surgery is indicated can be included (If a
partial mesorectal excision (PME) is indicated the patient should be excluded).
4. Pathological confirmation of the rectal adenocarcinoma fulfilling the
following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of
carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3,
tumour budding, lymphatic and/or venous invasion.
5. Pathological confirmation of the rectal adenocarcinoma fulfilling the
following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate
differentiated and without tumour budding or lymphatic or venous invasion.
6. Complete colonoscopy, without synchronous colorectal cancer
7. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be
considered as benign, independent of morphologic features. Staging done within
6 weeks before randomisation.
8. Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without
signs of distant metastasis (cM0)
9. Male or female, Age > 18 years.
10. Life expectancy of at least 12 months.
11. Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
12. No contraindications to chemotherapy, including adequate blood counts;
- white blood count >= 4.0 x 10 9/l
- platelet count >=100 x 109/l
- clinical acceptable haemoglobin levels
- bilirubin < 35 umol/l
- creatinine levels indicating renal clearance of >=50 ml/min
13. The patient is willing and able to comply with the protocol for the
duration of the study, and scheduled follow-up visits and examinations.
14. Written (signed and dated) informed consent and be capable of co-operating
with protocol.
1. Incomplete or inconclusive resection margin with macroscopic residual tumour.
2. T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without
sm3/Haggit 4,tumour budding, venous or lymphatic invasion.
3. T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 3 cm.
4. Presence of metastatic disease or recurrent rectal tumour.
5. Previous pelvic radiation.
6. Treatment with any other investigational agent, or participation in another
clinical trial that interferes with the outcomes within 28 days prior to
enrolment.
7. Concomitant malignancies, except for adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with
prior malignancies must be disease-free for at least 5 years.
8. Pregnancy, breast-feeding or fertile women without active birth control
9. Clinically significant (i.e. active) cardiovascular disease for example
cerebro vascular accidents (<6 months prior to randomization), myocardial
infarction (<6 months prior to randomization), unstable angina, New York Heart
Association (NYHA) grade II or higher, congestive heart failure, serious
cardiac arrhythmia requiring medication.
10. Patients who are known to be serologically positive for Hepatitis B,
Hepatitis C or HIV.
11. History of severe and unexpected reactions to fluoropyrimidine therapy.
12. Hypersensitivity to capecitabine.
13. Patients with severe hepatic impairment.
14. Medical or psychiatric conditions that compromise the patient's ability to
give informed consent.
15. Patients known with dihydropyrimidine dehydrogenase deficiency.
16. Any contra-indications to undergo MRI imaging.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is local recurrence after 3 year follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary mortality, morbidity, stoma rate, long term interventions, functional<br /><br>outcomes, health related quality of life (HRQoL) and costs.</p><br>