domingo, 10 de julio de 2011

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Three-dimensional conformal radiation therapy for non–small-cell lung cancer: A Phase I/II dose escalation clinical trial☆

Three-dimensional conformal radiation therapy for non–small-cell lung cancer: A Phase I/II dose escalation clinical trial☆
Kai-Liang Wu, M.D., Guo-Liang Jiang, M.D., Yuan Liao, Ph.D., Hao Qian, M.D., Li-Juan Wang, M.D., Xiao-Long Fu, M.D., Shen Zhao, M.D.

Purpose
A prospective Phase I/II dose escalation study was conducted to determine the maximum tolerated dose (MTD) in three-dimensional conformal radiation therapy (3D-CRT) for non–small-cell lung cancer (NSCLC).

Methods and materials
MTD would be reached via a dose escalation study. After 42 Gy/21 fractions, 4.2 weeks by conventional fractionated irradiation through anteroposterior/posteroanterior fields, the 3D-CRT technique was used as boost. The planned total dose escalation depended on lung volume irradiated. According to the percentage of lung volume receiving >20 Gy, the patients were divided into three subgroups (i.e., <25%, 25%–37%, and >37%). The scheduled dose escalation began with 69 Gy and continued to 78 Gy. The boost doses were delivered at 3 Gy per fraction, once per day, five fractions per week. Each dose level includes 5 patients. Besides radiotherapy, all patients received neoadjuvant and adjuvant chemotherapy with MVP regimen (Mitomycin, Vindesine, cis-platium). The criterion for stopping further dose escalation was ≥20% of patients with ≥RTOG Grade 3 radiation pneumonitis.

Results
Between June 1999 and February 2001, 50 patients had been enrolled in this study, including 4 with Stage II disease, 31 with Stage IIIa disease, and 15 with Stage IIIb disease. The dose escalation plan has been completed. All subgroups reached the highest predetermined dose levels (i.e., 78 Gy for the <25% subgroup, 78 Gy for the 25–37% subgroup, and 75 Gy for the >37% subgroup). Although none of the subgroups developed more than 20% of ≥Grade 3 acute pneumonitis, dose escalation was terminated because long-term follow-up was needed to observe late complications. Median follow-up time (MFT) for the entire group was 18 months (6–37 months). The most common acute complication was esophagitis in 56% of patients with RTOG Grade 1–2, and in 4% with Grade 3. Acute radiation pneumonitis developed in 36% of patients with RTOG Grade 1–2. Only 1 patient had Grade 3 pneumonitis, which was in the 25–37% subgroup at 75 Gy. The hematopoietic toxicity appeared in 58% of patients with Grade 1–2, and 8% with Grade 3. As to late complications, only 30% of patients developed pulmonary fibrosis of RTOG Grade 1–2. The median survival time for the entire group was 18 months. Two-year overall survival, locoregional progression-free rate, and distant metastasis rate were 44%, 40%, and 41%, respectively.

Conclusion
Although MFT was 18 months, it had not yet been declared because a longer follow-up was needed to observe the late complications. The 2-year overall survival of 44% was very encouraging and implied that 3D-CRT combined with chemotherapy would improve the outcome for locally advanced NSCLC.

CRUK/07/001: QUARTZ - A phase III multicentre randomised trial to assess dexamethasone +/- whole brain radiotherapy in patients with inoperable brain

Paula Mulvenna
Medical Research Council
01 January 2007 to 31 December 2013
Clinical Trials Awards & Advisory Committee - Late Phase Study
Funding committee - Clinical Trials Awards and Advisory Committe

Cerebral metastases, from any primary, are a devastating occurrence and most patients deteriorate quickly over a matter of weeks. A number of treatment options have been investigated, but for many years, the standard therapy for patients with inoperable brain metastases has remained a combination of steroids and Whole Brain Radiotherapy (WBRT). However, WBRT can be toxic and has not been shown to consistently improve length or quality of survival, particularly for patients with a non-small cell lung cancer primary.
The aim of this trial is to determine whether dexamethasone alone is as effective as dexamethasone plus WBRT in terms of overall quality of survival time for patients with inoperable brain metastases originating from non-small cell lung cancer, when both groups of patients are also receiving optimal supportive care At the time of referral to the oncology centre, the vast majority of patients will be receiving optimal supportive care (OSC) including dexamethasone for symptom relief. Patients will continue to receive this treatment and in addition will be allocated WBRT (20 Gy in 5 consecutive daily fractions) or not. Because these patients have a short survival time, and may not be well enough to be seen in clinic; a nurse will assess all patients via a weekly telephone call.

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