420 Conventional radiotherapy versus accelerated hyperfractionated radiotherapy versus conventional radiotherapy and concomitant chemotherapy in advanced oropharyngeal carcinoma: A randomized clinical trial

• Published in: European journal of cancer (1990) 1995-11, Vol.31, p.S91-S91
• Main Authors: Olmi, P., Fallai, C., Rossi, F., Crispino, S., Marsoni, S., Torri, V., Flann, M.
• Format: Article
• Language: English
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/0959-8049(95)95673-T

In January 1993 a phase III randomized trial (ORO-O1) was activated comparing conventional radiotherapy—RT–(arm A) versus accelerated hyperfractionated RT (arm B) versus conventional RT plus concomitant chemotherapy—CT (arm C). Previously untreated patients affected with epidermoid carcinoma of the oropharynx, stage III–IV M0 (according to UICC 1987) with the exclusion of T1N1 and T2N1, with KPS ≥ 70 and aged ≤ 70 are considered eligible. In the arm A a total tumor dose (TTD) of 66–70 Gy are given in 33–35 fractions over 6.5–7 weeks. In the arm B a TTD of 64–67.2 Gy is given in 40–42 fractions, two fractions of 1.6 Gy a day separated by 6 hours; a two-week split is planned after delivering 38.4 Gy. In the arm C RT is given in the same way as in the arm A: CT is administered according to the following schedule: carboplatin 75 mg/sqm bolus in days 1–4, 24–32, 57–59 and 5–FU 1000 mg/sqm in with continuous infusion over 96 hours (days 1–4, 29–32, 57–59). The first two cycles are given concomitantly with RT. Between January 1993 and January 1995 104 patients were accrued in 18 participating centers. Full information about participating centers will be given. The distribution of patients by treatment arm, according to age, gender and stage has been balanced in the three arms. Particularly for the stage the distribution has been the following: ARM A ST III 9, ST IV 26; ARM B ST III 12, IV 23; ARM C III 10, IV 24. The study is still on going. Preliminary data concerning clinical response at two months after the end of the treatment and also treatment compliance will be reported.