Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer

Conditions

Early rectal cancer Cancer Malignant neoplasm of rectum

Daamen LA, Westerhoff JM, Couwenberg AM, Braam PM, Rütten H, den Hartogh MD, Christodouleas JP, Hall WA, Verkooijen HM, Intven MPW.

2024-01-043 citations

10.1016/j.ctro.2023.100721

Quality-of-life outcomes in older patients with early-stage rectal cancer receiving organ-preserving treatment with hypofractionated short-course radiotherapy followed by transanal endoscopic microsurgery (TREC): non-randomised registry of patients unsuitable for total mesorectal excision.

Gilbert A, Homer V, Brock K, Korsgen S, Geh I, Hill J, Gill T, Hainsworth P, Tutton M, Khan J, Robinson J, Steward M, Cunningham C, Kaur M, Magill L, Russell A, Quirke P, West NP, Sebag-Montefiore D, Bach SP, TREC collaborators.

2022-11-1721 citations

10.1016/s2666-7568(22)00239-2

Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study.

Bach SP, Gilbert A, Brock K, Korsgen S, Geh I, Hill J, Gill T, Hainsworth P, Tutton MG, Khan J, Robinson J, Steward M, Cunningham C, Levy B, Beveridge A, Handley K, Kaur M, Marchevsky N, Magill L, Russell A, Quirke P, West NP, Sebag-Montefiore D, TREC collaborators.

2020-12-11122 citations

10.1016/s2468-1253(20)30333-2

RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial.

Burbach JP, Verkooijen HM, Intven M, Kleijnen JP, Bosman ME, Raaymakers BW, van Grevenstein WM, Koopman M, Seravalli E, van Asselen B, Reerink O.

2015-02-2253 citations

10.1186/s13063-015-0586-4

Interventions

A phase II open, multi-centre randomised controlled trial for patients with early rectal cancer comparing: 1. Conventional TME surgery 2. Short course pre-operative rad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biopsy proven adenocarcinoma 2. MRI defined stage I rectal cancer (less than or equal to pT2 N0) 3. Endorectal ultrasound defined rectal cancer less than or equal to uT2 4. Patients who have undergone submuscosal excision for a presumed villous adenoma that on histopathological examination contains discrete invasion less than 3 cm diameter 5. Aged 18 or over, either sex

Exclusion criteria

Exclusion criteria: 1. Familial/genetic cancer 2. T3+ or nodal involvement on radiological staging 3. Contraindications to radiotherapy 4. Previous pelvic radiotherapy 5. Metastatic disease 6. Unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Recruitment, measured at 12, 18 and 24 months	—

Secondary

Measure	Time frame
1. Safety: 1.1. 30-day mortality 1.2. 6-month mortality 1.3. Surgical morbidity 1.4. Bowel, bladder and sexual function (measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ] C29 and C30) 2. Efficacy: 2.1. Histopathological assessment of tumour down-staging according to depth of tumour invasion and the incidence of other high-risk features 2.2. Conversion rates from organ conservation to radical surgery	—

Measure

Time frame

1. Safety: 1.1. 30-day mortality 1.2. 6-month mortality 1.3. Surgical morbidity 1.4. Bowel, bladder and sexual function (measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ] C29 and C30) 2. Efficacy: 2.1. Histopathological assessment of tumour down-staging according to depth of tumour invasion and the incidence of other high-risk features 2.2. Conversion rates from organ conservation to radical surgery

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Countries

England, United Kingdom

Outcome results

None listed