Maor 1986.
Methods | Location of trial: US. Number of centres: 4. Funding: National Cancer Institute (core grant CA23113). Trial ID: RTOG 7808. |
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Participants | Inclusion criteria: untreated squamous cell carcinoma, T2‐T4, with any N but M0. Patients referred to trial following unsatisfactory response to initial radiotherapy. Exclusion criteria: more than 1 primary tumour or Karnofsky status < 50. Recruitment period: October 1978 to August 1982. OC: 30/115 (26%). OP: 59/115 (51%). OC+OP: 89/115 (77%). Number randomised: 118. Number analysed: 115. |
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Interventions |
Neutron boost versus photon boost Neutron boost (n = 57): to include only areas involved by gross tumour, primary, or nodes plus a margin of 2 cm. Boost given in 4‐6 fractions in 2‐3 weeks. Neutron dose depended on radiobiological effectiveness, equivalent to 25‐30 Gy photons. Photon boost (n = 58): to include areas with gross tumour plus a 1 cm margin (2 cm with cobalt). 25‐30 Gy over 2‐3 weeks in 5 daily fractions per week. All patients received 45‐50 Gy photons in daily fractions of 1.8‐2 Gy. |
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Outcomes | Primary outcome unclear. Tumour clearance, locoregional control, overall survival. |
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Notes | Data taken from Kaplan‐Meier graphs (no numbers at risk). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Randomisation stratified by institution, T stage and region and performed by central office. No details given but assumed adequate as for other RTOG trials. |
Allocation concealment? | Unclear risk | Insufficient information. |
Blinding ‐ Outcome Assessors | High risk | Not mentioned. |
Incomplete outcome data addressed? | Low risk | 3/118 excluded from the analysis. Unlikely to affect results. |
Free of selective reporting? | Low risk | Important outcomes of overall survival, local clearance, locoregional control planned and reported. |
Free of other bias? | High risk | 1 patient in neutron boost group and 5 in photon boost group received interstitial implants to deliver boost. |