Hypofractionated radiation therapy versus chemotherapy with temozolomide in patients affected by RPA class V and VI glioblastoma: a randomized phase II trial

2019 ◽  
Vol 143 (3) ◽  
pp. 447-455 ◽  
Author(s):  
Sara Pedretti ◽  
Laura Masini ◽  
Enrico Turco ◽  
Luca Triggiani ◽  
Marco Krengli ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Class V ◽  
Randomized Phase Ii ◽  
Hypofractionated Radiation Therapy ◽  
Hypofractionated Radiation

scholarly journals Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis

2018 ◽  
Vol 105 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Pierina Navarria ◽  
Federico Pessina ◽  
Luca Cozzi ◽  
Stefano Tomatis ◽  
Giacomo Reggiori ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Observation Time ◽  
Primary Objective ◽  
Karnofsky Performance Scale ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Hypofractionated Radiation Therapy ◽  
Hypofractionated Radiation

Objective: To evaluate hypofractionated radiation therapy (HFRT) given at therapeutic effective doses in a phase II study. Endpoints were progression-free survival (PFS) rate, overall survival (OS), and incidence of toxicity. Methods: Patients with newly diagnosed glioblastoma, age ⩾70 years, Karnofsky performance scale (KPS) score ⩽60, were enrolled. The total dose of HFRT was 52.5 Gy/15 fractions, corresponded to a biological effective dose to the tumor of 70.88 Gy. Results: Thirty patients were treated, with a median age of 75 years. Concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT) was administered in 7 (23.3%) and 11 (40.7%) patients received only adjuvant TMZ-CHT. The median, 6-month PFS, and 12-month PFS were 5.0 months, 43.3%, and 20%, respectively. The median, 6-month OS, and 12-month OS were 8 months, 90%, and 30%, respectively. At the last observation time, 26 patients (86.7%) were dead and 4 (13.3%) were alive. No increase in steroid drugs was required during radiotherapy treatment and a reduction was possible in 12 (40%). Patients with KPS=60, RPA V, MGMT methylated status, neurological status stable or improved after surgery and who underwent HFRT with concurrent and adjuvant CHT, had the better outcome. Conclusion: HFRT has proven to be feasible and effective, with limited morbidity, for selected elderly and frail patients with newly diagnosed glioblastoma. The primary objective of this study was not reached in the whole cohort but only in selected patients, who need more aggressive treatment.

Preliminary Results of Radiation Therapy Oncology Group 97-03: A Randomized Phase II Trial of Concurrent Radiation and Chemotherapy for Advanced Squamous Cell Carcinomas of the Head and Neck

2004 ◽  
Vol 22 (14) ◽  
pp. 2856-2864 ◽  
Author(s):  
A.S. Garden ◽  
J. Harris ◽  
E.E. Vokes ◽  
A.A. Forastiere ◽  
J.A. Ridge ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Head And Neck ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Radiation Therapy Oncology Group ◽  
Squamous Carcinoma ◽  
Institutional Setting ◽  
Oncology Group ◽  
Randomized Phase Ii ◽  
To Receive

Purpose To define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck. Patients and Methods The Radiation Therapy Oncology Group developed this three-arm randomized phase II trial. Patients with stage III or IV squamous carcinoma of the oral cavity, oropharynx, or hypopharynx were eligible. Each of three arms proposed a radiation schedule of 70 Gy in 35 fractions. Patients on arm 1 were to receive cisplatin 10 mg/m2 daily and fluorouracil (FU) 400 mg/m2 continuous infusion (CI) daily for the final 10 days of treatment. Treatment on arm 2 consisted of hydroxyurea 1 g every 12 hours and FU 800 mg/m2/d CI delivered with each fraction of radiation. Arm 3 patients were to receive weekly paclitaxel 30 mg/m2 and cisplatin 20 mg/m2. Patients randomly assigned to arms 1 and 3 were to receive their treatments every week; patients on arm 2 were to receive their therapy every other week. Results Between 1997 and 1999, 241 patients were entered onto study; 231 were analyzable. Ninety-two percent, 79%, and 83% of patients on arms 1, 2, and 3, respectively, were able to complete their radiation as planned or with an acceptable variation. Fewer than 10% of patients had unacceptable deviations or incomplete chemotherapy in the three arms. Estimated 2-year disease-free and overall survival rates were 38.2% and 57.4% for arm 1, 48.6% and 69.4% for arm 2, and 51.3% and 66.6% for arm 3. Conclusion We have demonstrated that three different approaches of concurrent multiagent chemotherapy and radiation were feasible and could be delivered to patients in a multi-institutional setting with high compliance rates.

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