Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of additional surgery versus additional chemoradiotherapy after local excision for early rectal cancers.

• Conditions: Patients with a margin free (at least 1 mm) endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm). According to current guidelines these patients require additional surgery after the local excision due to tumor characteristics; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000689-79-NL
• Lead Sponsor: Vrije Universiteit Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-09
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patient has had a margin free (at least 1 mm) endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm).
2. Only lesions for which TME surgery is indicated can be included (If a partial mesorectal excision (PME) is indicated the patient should be excluded).
3.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm or pT1, maximum size 3 cm, with at least poor differentiation and/or lymphatic and/or venous invasion
4.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size 3 cm, well differentiated and without lymphatic or venous invasion.
5.Complete colonoscopy, without synchronous colorectal cancer
6.cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features .
7.Adequate distant staging (CT-thorax abdomen) without signs of distant metastasis (cM0)
8.Male or female, Age > 18 years.
9.Life expectancy of at least 12 months.
10.Medically fit (WHO 0-2) to undergo radical surgery and/or radiation
11.The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
12.Written (signed and dated) informed consent and be capable of co-operating with protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

1.Incomplete or inconclusive resection margin (less than 1mm clearance from the local excision margin or specimens with uncertain deep margin).
2.T1 tumour < 3 cm, well differentiated, without venous or lymphatic invasion.
3.T1 tumour >5 cm and T2 tumour > 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 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 leukopenia, neutropenia, or thrombocytopenia.
14.Patients with severe hepatic impairment. 15.Patients with severe renal impairment (creatinine clearance below 30 ml/min).
16. Medical or psychiatric conditions that compromise the patient's ability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified