Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
Brief Summary: Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated with substantial loss of health related quality of life due to defecation disorders, incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are acceptable when radical surgery is the only option for cure. Advances in technology enabled the development of local excision of early rectal cancer with precise endoluminal microsurgery or local endoscopic excision resulting in a significant decrease in short- and long term morbidity. However current evidence is of inadequate quality to conclude on the oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment of the excised tumor tissue provides the optimal information on tumor stage, tumor characteristics and tumor differentiation, thereby it enables to predict the risk of recurrence after local treatment alone. For early rectal cancers, with a low risk on recurrence based on favourable tumor characteristics local excision is seen as safe and these patients do not require an additional treatment. However, for patients with early rectal cancer with a higher risk on recurrence based on tumor characteristics there is no consensus on the additional treatment after local excision. According to the National guideline these patients receive a TME procedure. However, for this subgroup of patients local treatment followed by chemoradiotherapy might also be oncological safe. Current evidence is of inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be randomised after local endoluminal excision between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up.


Options:
A: Arm Label: Transanal Endoscopic Microsurgery; Type: EXPERIMENTAL; Interventions: Procedure: ELRR BY TEM | Arm Label: Total Mesorectal Excision; Type: ACTIVE_COMPARATOR; Interventions: Procedure: LTME | Intervention Type: PROCEDURE; Name: ELRR BY TEM; Assigned to Arm(s): Transanal Endoscopic Microsurgery | Intervention Type: PROCEDURE; Name: LTME; Assigned to Arm(s): Total Mesorectal Excision
B: Arm Label: Total Mesorectal Excision; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Additional TME surgery | Arm Label: Adjuvant chemoradiotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Adjuvant chemoradiotherapy, Drug: capecitabine | Intervention Type: RADIATION; Name: Adjuvant chemoradiotherapy; Assigned to Arm(s): Adjuvant chemoradiotherapy | Intervention Type: PROCEDURE; Name: Additional TME surgery; Assigned to Arm(s): Total Mesorectal Excision | Intervention Type: DRUG; Name: capecitabine; Assigned to Arm(s): Adjuvant chemoradiotherapy
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: local rectal excision | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: total mesorectal excision | Intervention Type: PROCEDURE; Name: local rectal excision; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: total mesorectal excision; Assigned to Arm(s): 2
D: Arm Label: Standard TME surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard TME surgery | Arm Label: Long course concurrent chemoradiation; Type: EXPERIMENTAL; Interventions: Drug: Long course concurrent chemoradiation with capecitabine and radiotherapy | Arm Label: Short course radiotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Short course radiotherapy | Intervention Type: PROCEDURE; Name: Standard TME surgery; Assigned to Arm(s): Standard TME surgery | Intervention Type: DRUG; Name: Long course concurrent chemoradiation with capecitabine and radiotherapy; Assigned to Arm(s): Long course concurrent chemoradiation | Intervention Type: RADIATION; Name: Short course radiotherapy; Assigned to Arm(s): Short course radiotherapy

Answer: B