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. 2018 Oct 3;2018(10):CD002102. doi: 10.1002/14651858.CD002102.pub3

Marsh 1994.

Methods Randomisation method not available. Enrolment period: 1982 to 1986
 Abdominal imaging: not stated
 Chest imaging: not stated
 Study arm: 143 randomised, 0 excluded; median time from randomisation to surgery 27 days (IQR 21 to 33)
 Control arm: 141 randomised , 0 excluded; median time from randomisation to surgery 19 days (IQR 12 to 26)
Participants Rectal cancer
 Location: </= 13 cm
 Resectability: locally advanced (tethered or fixed) but operable (within 13 cm of the anal verge)
Interventions Surgery: not stated
 RT: 2000 in 4 fr
 BED: 31.8 Gy10
 RT volume: 10x10x10 cm posterior pelvis
 RT‐S: </= 1 week
 Technique: rotational field
 Co‐intervention: none
Outcomes
  • Duration of FU: minimum 96 months

  • Perioperative mortality: not stated

  • Mets @ lap: not given

  • Curative resection: S 75/141, RTS group 69/143

  • Overall resection: S 121/141, RTS 118/143

  • Compliance to radiotherapy: 6/143 did not receive protocol therapy, with 2 < 20 Gy and 4 > 20 Gy

  • Overall survival: yes

  • Cause‐specific survival: yes

  • Tox post RT: not reported

  • Acute toxicity postsurgery: not reported

  • Late toxicity postsurgery: not reported

  • Local recurrence: yes

  • Quality of life: not reported

  • Others: subgroup analysis for participants treated by curative surgery only. Survival outcome in relationship flow cytometry in a subgroup of 186 participants treated at 1 institution

Notes Definition for:
  • Local recurrence: by clinical examination +/‐ pathology or CT scan, include patients with known residual at surgery

  • Postoperative mortality: not reported

  • Toxicity classification: not reported

  • Quality of life: not reported

  • Quality score: 0.57

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It was unclear how the method of randomisation was performed.
Allocation concealment (selection bias) Unclear risk It was unclear how allocation of participants was concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding is not possible with the type of intervention.
Blinding the outcome assessor (detection bias; objective outcomes) Outcomes: mortality; local recurrence; distant metastases; curative resection 
 Outcomes: mortality; local recurrence; distant metastases; any recurrence; curative resection Low risk Mortality: no information was provided on the blinding of the outcome evaluator.
Recurrence: no information was provided on the blinding of the outcome evaluator.
Metastases: no information was provided on the blinding of the outcome evaluator.
Curative resection: It was unclear whether the operating surgeon or the pathologist was blinded. Quote: "The operating surgeon recorded a 'curative' resection if the carcinoma was removed with neither spillage nor perforation, and there was no macroscopic evidence of residua I local disease or distant metastases. The degree of local invasion present at operation was also noted. Pathologic information on the resected tumour was recorded prospectively by pathologists from the referral hospital on a standard form for each of the 284 patients. Lymph nodes were sampled and assessed in the normal way, as was the presence of venous invasion."
Since the outcomes were objective, we considered the study to be at low risk of detection bias for the listed outcomes.
Blinding the outcome assessor (detection bias): subjective outcomes: Postoperative morbidity; sphincter preservation; acute and late toxicities; quality of life 
 Outcomes: Postoperative morbidity; sphyncter preservation Unclear risk Postoperative morbidity was not assessed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Although intention‐to‐treat was not stated, it appears that all participants were analysed according to their initial allocation. No apparent significant loss to follow‐up
Selective reporting (reporting bias) Low risk Relevant clinical outcomes were considered.