The RTOG 0129 study was registered with the National Cancer Institute and approved by the institutional review boards at the participating centers. All patients provided written informed consent. The authors attest to the fidelity of the article to the full protocol and statistical-analysis plan.
Eligibility criteria were the presence of untreated, pathologically confirmed, stage III or IV squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx without distant metastases (M0)7 ; Zubrod’s performance status score of 0 or 1 (asymptomatic or symptomatic but ambulatory, respectively)8 (link); age of 18 years or older; and adequate bone marrow, hepatic, and renal function. Lifetime tobacco exposure was determined at enrollment with the use of a standardized, self-administered questionnaire.
Patients were stratified on the basis of the tumor site (larynx vs. other), nodal stage (N0 vs. N1, N2a, or N2b vs. N2c or N3), and Zubrod’s performance status score (0 vs. 1) and were randomly assigned to receive high-dose cisplatin concurrently with either accelerated-fractionation radiotherapy (with the acceleration provided by means of concomitant boost radiotherapy) or standard-fractionation radiotherapy. The accelerated-fractionation radiotherapy consisted of the delivery of 72 Gy in 42 fractions over a 6-week period, with a concomitant boost of twice-daily irradiation for 12 treatment days (as previously reported9 (link)), and standard-fractionation radiotherapy consisted of the delivery of 70 Gy in 35 fractions (i.e., 2 Gy per fraction) over a 7-week period. Intravenous cisplatin was administered at a dose of 100 mg per square meter of body-surface area on days 1 and 22 in the accelerated-fractionation radiotherapy group and on days 1, 22, and 43 in the standard-fractionation radiotherapy group.
Acute toxicity was evaluated weekly during the period of therapy according to the Common Terminology Criteria, version 2.0 (http://ctep.info.nih.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf ). To assess tumor status and late toxicity, according to RTOG criteria,10 (link) physical examinations and imaging studies were performed every 3 months for the first 2 years, every 6 months during years 3 through 5, and annually thereafter.
Eligibility criteria were the presence of untreated, pathologically confirmed, stage III or IV squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx without distant metastases (M0)7 ; Zubrod’s performance status score of 0 or 1 (asymptomatic or symptomatic but ambulatory, respectively)8 (link); age of 18 years or older; and adequate bone marrow, hepatic, and renal function. Lifetime tobacco exposure was determined at enrollment with the use of a standardized, self-administered questionnaire.
Patients were stratified on the basis of the tumor site (larynx vs. other), nodal stage (N0 vs. N1, N2a, or N2b vs. N2c or N3), and Zubrod’s performance status score (0 vs. 1) and were randomly assigned to receive high-dose cisplatin concurrently with either accelerated-fractionation radiotherapy (with the acceleration provided by means of concomitant boost radiotherapy) or standard-fractionation radiotherapy. The accelerated-fractionation radiotherapy consisted of the delivery of 72 Gy in 42 fractions over a 6-week period, with a concomitant boost of twice-daily irradiation for 12 treatment days (as previously reported9 (link)), and standard-fractionation radiotherapy consisted of the delivery of 70 Gy in 35 fractions (i.e., 2 Gy per fraction) over a 7-week period. Intravenous cisplatin was administered at a dose of 100 mg per square meter of body-surface area on days 1 and 22 in the accelerated-fractionation radiotherapy group and on days 1, 22, and 43 in the standard-fractionation radiotherapy group.
Acute toxicity was evaluated weekly during the period of therapy according to the Common Terminology Criteria, version 2.0 (
