Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: STAR-TREC: Can We Save the Rectum by Watchful Waiting or TransAnal Surgery Following (chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?
Brief Summary: Bowel cancer is the second most common tumour with 41 000 new cases diagnosed annually in the UK, 447 000 across Europe and 1.36 million worldwide; of which one third are located in the rectum. Standard primary radical Total Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in approximately 10% of cases while many more patients have a temporary stoma, some of which are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic tumours, may not be the optimal method of treatment for early screen-detected tumours and an organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes.

STAR-TREC is a rolling phase II/III study. Phase II aimed to assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus two contrasting organ saving treatments followed by selective transanal microsurgery. Phase III will evaluate two contrasting organ preservation strategies in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).


Options:
A: 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
B: Arm Label: Chemoradiotherapy+TEM; Type: ACTIVE_COMPARATOR; Interventions: Drug: Capecitabine (Xeloda), Radiation: 50.4 Gy, Procedure: Transanal Endoscopic Microsurgery | Arm Label: Total Mesorectal Excision; Type: OTHER; Interventions: Procedure: Total Mesorectal Excision | Intervention Type: DRUG; Name: Capecitabine (Xeloda); Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: RADIATION; Name: 50.4 Gy; Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: PROCEDURE; Name: Transanal Endoscopic Microsurgery; Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: PROCEDURE; Name: Total Mesorectal Excision; Assigned to Arm(s): Total Mesorectal Excision
C: Intervention Type: DRUG; Name: fluorouracil; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A
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: D