AT-13 * R9802: PHASE III STUDY OF RADIATION THERAPY (RT) WITH OR WITHOUT PROCARBAZINE, CCNU, AND VINCRISTINE (PCV) IN LOW-GRADE QLIOMA: RESULTS BY HISTOLOGIC TYPE

PURPOSE Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus–associated oropharyngeal squamous cell carcinoma (OPSCC). Whether reduced-dose radiation produces disease control and QOL equivalent to standard chemoradiation is not proven. PATIENTS AND METHODS In this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with ≤ 10 pack-years of smoking received 60 Gy of intensity-modulated radiation therapy (IMRT) over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT over 5 weeks. To be considered for a phase III study, an arm had to achieve a 2-year progression-free survival (PFS) rate superior to a historical control rate of 85% and a 1-year mean composite score ≥ 60 on the MD Anderson Dysphagia Inventory (MDADI). RESULTS Three hundred six patients were randomly assigned and eligible. Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85% ( P = .04). For IMRT, 2-year PFS was 87.6% ( P = .23). One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively. Two-year overall survival rates were 96.7% for IMRT + C and 97.3% for IMRT. Acute adverse events (AEs) were defined as those occurring within 180 days from the end of treatment. There were more grade 3-4 acute AEs for IMRT + C (79.6% v 52.4%; P < .001). Rates of grade 3-4 late AEs were 21.3% and 18.1% ( P = .56). CONCLUSION The IMRT + C arm met both prespecified end points justifying advancement to a phase III study. Higher rates of grade ≥ 3 acute AEs were reported in the IMRT + C arm.

Download Full-text

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide Versus Conventional Radiation Therapy for Multiple Brain Metastases (RTOG 0118)

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2007.09.016 ◽

2008 ◽

Vol 71 (1) ◽

pp. 79-86 ◽

Cited By ~ 68

Author(s):

Jonathan P.S. Knisely ◽

Brian Berkey ◽

Arnab Chakravarti ◽

Al W.K. Yung ◽

Walter J. Curran ◽

...

Keyword(s):

Radiation Therapy ◽

Brain Metastases ◽

Phase Iii ◽

Multiple Brain Metastases ◽

Conventional Radiation ◽

Phase Iii Study ◽

Conventional Radiation Therapy

Download Full-text

A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.4506 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 4506-4506 ◽

Cited By ~ 84

Author(s):

P. J. Loehrer ◽

M. E. Powell ◽

H. R. Cardenes ◽

L. Wagner ◽

J. M. Brell ◽

...

Keyword(s):

Pancreatic Cancer ◽

Radiation Therapy ◽

Phase Iii ◽

Unresectable Pancreatic Cancer ◽

Phase Iii Study

Download Full-text

Vincristine (V), dactinomycin (A), and lower doses of cyclophosphamide (C) with or without radiation therapy for patients with newly diagnosed low-risk embryonal rhabdomyosarcoma (ERMS): A report from the Children’s Oncology Group (COG).

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9509 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9509-9509 ◽

Cited By ~ 3

Author(s):

David Walterhouse ◽

Alberto S. Pappo ◽

Jane L Meza ◽

John C. Breneman ◽

Andrea Anita Hayes-Jordan ◽

...

Keyword(s):

Radiation Therapy ◽

Complete Response ◽

Low Risk ◽

Phase Iii ◽

Newly Diagnosed ◽

Group Iii ◽

Group I ◽

Phase Iii Study ◽

Stage 1

9509 Background: Intergroup Rhabdomyosarcoma Study (IRS) trials showed improved survival with VAC compared with VA for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II ERMS (see table). In COG ARST0331, we hypothesized that VA in combination with lower doses of C (total cumulative dose=4.8 g/m2) would produce the benefit of IRS-IV VAC with less toxicity for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II low-risk ERMS. Methods: This single arm, non-inferiority, phase III study enrolled newly diagnosed patients with Stage 1 Group III (non-orbit) ERMS or Stage 3 Group I/II ERMS onto Subset 2. Therapy was 4 cycles of VAC followed by 12 cycles of VA over 46 weeks (total cumulative doses: V=54 mg/m2, A=21.6 mg/m2, C=4.8 g/m2). The radiation therapy dose was 36 Gy for Group IIA patients, 41.4 Gy for Group IIB/C patients, and 50.4 Gy for Group III patients. From 2004–2008 girls with Group III vaginal RMS did not receive radiotherapy if a complete response was achieved with chemotherapy with or without delayed resection. The primary endpoint was failure-free survival (FFS), and results were compared with a fixed expected outcome. Results: With a median follow-up of 3.0 yrs, we observed 16 failures vs. 7.8 expected failures. Estimated 3-yr FFS was 63% (95% CI: 46%, 75%) (n=60), and overall survival (OS) was 84% (95% CI: 68%, 93%). Estimated 3-yr FFS was 46% (95% CI: 23%, 67%) for girls with non-bladder genitourinary tract ERMS (n=21) and 75% (95% CI: 53%, 88%) for all other Subset 2 patients (n=39). Conclusions: We observed suboptimal FFS of patients with Subset 2 low-risk RMS using reduced total cyclophosphamide (4.8 g/m2). Results were complicated by the choice of no radiation therapy for girls with vaginal tumors. Future studies for low-risk RMS Subset 2 patients could investigate a dose of C between 4.8 and 26.4 g/m2 with VA and local radiotherapy. [Table: see text]

Download Full-text

Phase II double-blind placebo-controlled study of armodafinil for brain radiation induced fatigue.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.9505 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 9505-9505 ◽

Cited By ~ 4

Author(s):

Edward G. Shaw ◽

Doug Case ◽

David Bryant ◽

David Grisell ◽

Glenn Lesser ◽

...

Keyword(s):

Cognitive Function ◽

Phase Ii ◽

Concurrent Chemotherapy ◽

Phase Iii ◽

Controlled Study ◽

Low Grade ◽

Eligibility Criteria ◽

Double Blind ◽

Phase Iii Study ◽

Brain Radiation

9505 Background: Armodafinil (ARM), the R-enantiomer of modafinil, is FDA approved for narcolepsy, shift work disorder, and treated sleep-apnea, and has also been shown to reduce fatigue/improve cognitive function in cancer patients. This phase II study estimated the efficacy and toxicity of ARM in primary brain tumor (PBT) patients receiving brain radiation therapy (RT) to determine whether a larger phase III study would be warranted. Methods: Eligibility criteria – adult, PBT, total RT dose >45Gy, KPS>60, no severe headaches, and concurrent chemotherapy allowed. Patients were assessed at baseline, end of RT, then 4 weeks after end RT with the Brief Fatigue Inventory (BFI), Epworth Sleep Scale (ESS), FACT, and FACT brain and FACIT fatigue subscales. Patients were randomized to receive ARM 150mg/day during RT and for 4 weeks after RT or placebo (PLAC). Results: 54 patients enrolled between 9/10-12/12; 26 to ARM, 28 to placebo PLAC. Median age 59; 59% female; 95% White; 41% KPS 90-100, 59% KPS 60-80; 74% malignant glioma, 26% low-grade glioma/benign histology. 83% patients had concurrent chemotherapy. For all randomized patients, there were no statistically significant differences in outcome between ARM and PLAC groups at end-RT vs. baseline or 4 weeks post RT vs. baseline. For patients who had more baseline fatigue (fatigue subscale score <median), ARM-treated patients had significantly/suggestively better outcomes at end-RT vs. baseline compared to PLAC-treated patients: less fatigue (BFI p=0.056, fatigue subscale p=0.0295), less sleepiness (ESS p=0.1034), and better QOL (FACT p=0.0001). Incidence of grade 2/3 toxicities was the same between the two treatment groups: 7% anxiety, 7% nausea, 18% headaches, and 20% insomnia. There were no grade 4 or 5 toxicities. Conclusions: In irradiated PBT patients, fatigue, sleepiness, and reduced QOL occurring at the end of brain RT was less with ARM in those patients who were more fatigued at baseline. Toxicity was minimal. These data support conducting a larger phase III study. Analysis of cognitive function data is ongoing. Support - NIH/NCI grant 2U10 CA 81851 and Teva Pharmaceuticals. Clinical trial information: 95709.

Download Full-text