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Referencias

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Ogoltsova 1990

Methods

Randomised controlled trial

Participants

234 patients with T1 or T2 glottic carcinoma

Interventions

Open surgery versus radiotherapy

Outcomes

Disease‐free survival
Overall survival

Notes

Method of concealment of allocation unclear

Total number of patients randomised and total number randomised to each group unclear

No comparison of baseline characteristics at entry

Radiotherapy regimens might be considered sub‐optimal

Numbers of patients at risk and number of events at specified time points not stated

Inconsistencies between text and tables

Statistical tests quoted at the one‐sided 5% level but this is not explicit in the text

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

The total number of patients randomised to each treatment arm is not provided and data are not available on the baseline characteristics of treatment groups at study entry. The number of patients evaluated in each group is unbalanced.

Allocation concealment (selection bias)

Unclear risk

Randomisation was by consecutive number generation, however it is not stated whether clinicians were blinded to this process. The numbers treated in each group were unbalanced and the total initially randomised to each group is not stated. Baseline characteristics between the 2 groups are not provided.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of treatments was not possible in this study due to the nature of treatments

Incomplete outcome data (attrition bias)
All outcomes

High risk

Difficulties completing follow‐up and loss of patients to follow‐up during the study is mentioned

Selective reporting (reporting bias)

Unclear risk

The number of patients with glottic cancer evaluated in each arm is not provided. The number of patients in each arm available for outcome evaluation at specified time points is not available.

Other bias

High risk

The investigators suggest that patients may have been inadequately staged before treatment. Surgical interventions were not standardised and the radiotherapy regimens may be sub‐optimal, with neither treatment volume nor technique stated.

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Abdurehim 2009

Study abandoned due to difficulty recruiting patients

Hintz 1979

ALLOCATION:
Random, concealed, not stratified by site

PARTICIPANTS:
Patients diagnosed with squamous carcinoma of any head and neck site between 1971 and 1976. Only 24 patients had early glottic cancer; 7 T2 cancers allocated radiotherapy and one allocated surgery

INTERVENTIONS:
Radiotherapy and surgery. Radiotherapy regimen may be sub‐optimal

OUTCOME MEASURES:
Local control rates, voice function. Analysis not on an intention‐to‐treat basis

Li 1993

ALLOCATION:
Stratified randomisation, concealment unclear

PARTICIPANTS:
Patients diagnosed with laryngeal cancer (all histological and clinical types and stage). Only 25 patients had early glottic cancer

INTERVENTIONS:
Preoperative radiotherapy and surgery compared with surgery alone. 14 patients with early glottic laryngeal cancer randomised to surgery alone

OUTCOME MEASURES:
3‐ and 5‐year survival; postoperative infection rate

Yin 2000

(Information derived from conference proceedings abstract only)

ALLOCATION:
Following surgery, method unclear, concealment unclear

PARTICIPANTS:
92 patients; stage unclear

INTERVENTIONS:
Surgery and postoperative radiotherapy compared with surgery alone

OUTCOME MEASURES:
3‐ and 5‐year survival

Characteristics of studies awaiting assessment [ordered by study ID]

Ir a:

Coman 2003

Methods

Randomised controlled trial

Participants

Patients with T1 or T2 N0 M0 glottic cancer

Interventions

Laser surgery using CO2 laser

Radiotherapy (EBRT 60 to 66 Gy for 5 days a week over 6 to 6.5 weeks)

Outcomes

Primary outcomes:

Local control
Voice quality
Swallowing function
Quality of life
Nutrition
Cost of treatment

Secondary outcomes:

Degree of larynx preservation
Loco‐regional control
Disease‐specific survival rate
Quantitative and qualitative evaluation of toxicity aspects of treatment

Notes

Not able to establish recent contact with principal investigator to determine current status of trial

EaStER 2006

Methods

Randomised controlled trial

Participants

Patients with Tis, Tis T1 T2a N0 M0 carcinoma of the glottis

Interventions

Endoscopic excision: cold steel or laser

Radiotherapy: Tis T1 non bulky tumours 50 Gy
T1 bulky T2a 55 Gy

Outcomes

Primary outcome:

Loco‐regional recurrence

Secondary outcomes:

Voice quality
Quality of life
Morbidity
Mortality
Economic assessment

Notes

This study is closed and recruited only 17 patients to the trial, however the patients were reported as being followed up, so the status is unknown. It is said that this study has shown that endoscopic excision is the preferred treatment option (Bradley 2009).

Characteristics of ongoing studies [ordered by study ID]

Ir a:

Saedi 2007

Trial name or title

The comparison of voice quality in early laryngeal cancer between surgery and radiotherapy

Methods

Randomised, controlled, single‐blind study

Participants

Patients with early laryngeal cancer

Interventions

Partial laryngectomy versus radiotherapy

Outcomes

Voice quality at 3 to 6 months
Quality of life at 6 months

Starting date

March 2007

Contact information

Professor Babak Saedi, Imam Khomainee Hospital, Tehran, Iran
E‐mail: [email protected]

Notes

Published results were expected in 2013 but have not yet been published

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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