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INT 0123

INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy

Phase 3N = 236NCT00002631

Population
Clinical stage T1 to T4, N0/1, M0 squamous-cell carcinoma or adenocarcinoma of the oesophagus, selected for a non-surgical approach
Design
Randomised phase III trial of four monthly cycles of fluorouracil (1000 mg/m2/24 hours for 4 days) and cisplatin (75 mg/m2 bolus day 1) with concurrent 64.8 Gy (high dose) versus 50.4 Gy (standard dose). 236 patients randomised, 218 eligible; stopped after an interim analysis. Median follow-up 16.4 months for all patients and 29.5 months for patients still alive. No trial register number is recorded in PubMed. ClinicalTrials.gov record NCT00002631 (RTOG-9405, secondary id INT-0123) lists an estimated enrolment of 298, the planned target; the paper randomised 236.
Arms
  • Standard-dose radiotherapy (control): Fluorouracil and cisplatin with concurrent 50.4 Gy radiotherapy
  • High-dose radiotherapy (experimental): Fluorouracil and cisplatin with concurrent 64.8 Gy radiotherapy
People
Minsky BD, Radiation Therapy Oncology Group
Δ median OS−5.1 monthsΔ 24-month OS−9 points
Show the numbers
Results reported for INT 0123
EndpointAnalysisHigh-dose radiotherapyStandard-dose radiotherapyEffect
OS218 eligible patientsinterimMinsky 2002median 13 months; 31% at 2 ymedian 18.1 months; 40% at 2 yThe abstract states there was no significant difference and gives no P value or hazard ratio. Local/regional failure and persistence of disease: 56% (high dose) vs 52% (standard dose). Treatment-related deaths: 11 in the high-dose arm and 2 in the standard-dose arm, 7 of the 11 in patients who had received 50.4 Gy or less.
Results reported for INT 0123
EndpointAnalysisHigh-dose radiotherapyStandard-dose radiotherapyEffect
OS218 eligible patientsinterimMinsky 2002median 13 months; 31% at 2 ymedian 18.1 months; 40% at 2 yThe abstract states there was no significant difference and gives no P value or hazard ratio. Local/regional failure and persistence of disease: 56% (high dose) vs 52% (standard dose). Treatment-related deaths: 11 in the high-dose arm and 2 in the standard-dose arm, 7 of the 11 in patients who had received 50.4 Gy or less.
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%010203040Months (modelled)
  • High-dose radiotherapy (experimental)
  • Standard-dose radiotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsHigh-dose radiotherapyStandard-dose radiotherapy
0100.0%100.0%
1155.6%65.6%
2329.3%41.4%
3416.3%27.2%
459.1%17.8%
Primary publication: Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, et al. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002;20(5):1167-74. PubMedDOI

Appears in

Sources

  1. Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, et al. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002;20(5):1167-74.

    PubMedDOI