Table 2. Reported clinical trials combining LDFRT with chemotherapy in solid tumors.
Clinical trial parameters | Induction regimen | Phase I | Phase II | |||||
---|---|---|---|---|---|---|---|---|
Site | Locally advanced SCCHN | Recurrent ovarian fallopian tube/peritoneal cancers | Locally advanced pancreatic or small bowel adenocarcinoma | Stage III/IV endometrial carcinoma | Recurrent/progressive GBM | Stage IIA/B-IIIA breast cancer | Recurrent NSCLC | |
Design | Paclitaxel (225 mg/m2), carboplatin (area under the curve of 6), and four 80-cGy fractions of radiotherapy (two each on days 1 and 2). This sequence was repeated on days 22 and 23 | One of three dose levels of docetaxel (20, 25, or 30 mg/m2) weekly with concurrent LDFRT given as 60 cGy bid 2 days weekly for 6 weeks | Gemcitabine 1,250 mg/m2 at 10 mg/m2/min on days 1 and 8 of a 3-week cycle. LDFRT at two dose levels: 60 cGy per fraction and 70 cGy per fraction on days 1, 2, 8, and 9 for 4 weeks | Six weekly cycles of FD-CDDP (40 mg/m2, maximum 70 mg IV) + LDFRT at 0.5 Gy/fx (total 3 Gy) and 0.75 Gy/fx (total 4.5 Gy) | LDFRT 0.3 Gy twice daily with cisplatin and fotemustine if progressing on temozolomide, or 0.4 Gy twice daily with temozolomide if recurrent | LDFRT 0.4 Gy/per fraction, 2 fractions per day, for 2 days, every 21 days for 6-8 cycles) with non-pegylated liposomal doxorubicin and docetaxel | Pemetrexed (500mg/m2 IV) and concurrent LDFRT (40cGy bid on days 1 and 2) was repeated fourfold every 21 days | |
Duration | 5 years | 2 years | 37 months | 27 months | 20 months | 2 years | ||
Recruitment | 40 | 13 | 10 | 12 | 26 | 10 | 19 | |
References | Arnold et al. (34); Gleason Jr et al. (35) | Kunos et al. (36) | Regine et al. (37) | Wrenn et al. (38) | Balducci et al. (39) | Nardone et al. (40) | Mantini et al. (41) |
LDFRT, Low Doses Fractionated Radiation Therapy.