Phase i trials involving radiation therapy, quantifying the risks

Journal of Medical Imaging and Radiation Oncology

Volumn 57, Issue 6, 2013, Pages 719-724

  Lawrence, Yaacov Richard ^a,b   Glass, Charles ^a   Symon, Zvi ^b   Dicker, Adam P ^a   Den, Robert B ^a  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b SHEBA MEDICAL CENTER   (Israel)

Author keywords

clinical trial; drug toxicity; neoplasms; phase I; radiation oncology; radiation sensitizing agents

Indexed keywords

ARTICLE; BILIARY TRACT CANCER; BIOLOGICAL THERAPY; BRAIN CANCER; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CHEMORADIOTHERAPY; DEATH; DEMOGRAPHY; HEAD AND NECK CANCER; HUMAN; LUNG CANCER; META ANALYSIS; PANCREAS CANCER; PELVIS CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RADIATION INJURY; RETROSPECTIVE STUDY; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE; STUDY DESIGN; SYSTEMATIC REVIEW;

CLINICAL TRIAL; DRUG TOXICITY; NEOPLASMS; PHASE I; RADIATION ONCOLOGY; RADIATION-SENSITIZING AGENTS;

AGE DISTRIBUTION; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; COMORBIDITY; EVIDENCE-BASED MEDICINE; HUMANS; INCIDENCE; NEOPLASMS; RADIOTHERAPY, CONFORMAL; RISK ASSESSMENT; SEX DISTRIBUTION; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 84889259745     PISSN: 17549477     EISSN: 17549485     Source Type: Journal    
DOI: 10.1111/1754-9485.12082     Document Type: Article

References (27)

1. Koyfman SA, Agrawal M, Garrett-Mayer E, et al. Risks and benefits associated with novel phase 1 oncology trial designs. Cancer 2007; 110: 1115-1124. (Pubitemid 47312878)
2. Roberts TG Jr, Goulart BH, Squitieri L, et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004; 292: 2130-2140. (Pubitemid 39435104)
3. Horstmann E, McCabe MS, Grochow L, et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 2005; 352: 895-904. (Pubitemid 40300298)
4. Soares HP, Kumar A, Daniels S, et al. Evaluation of new treatments in radiation oncology: are they better than standard treatments? JAMA 2005; 293: 970-978. (Pubitemid 40271129)
5. Wolff RA, Evans DB, Gravel DM, et al. Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma. Clin Cancer Res 2001; 7: 2246-2253. (Pubitemid 32751621)
6. Komaki R, Swann RS, Ettinger DS, et al. Phase I study of thoracic radiation dose escalation with concurrent chemotherapy for patients with limited small-cell lung cancer: Report of Radiation Therapy Oncology Group (RTOG) protocol 97-12. Int J Radiat Oncol Biol Phys 2005; 62: 342-350. (Pubitemid 40704448)
7. Camacho LH, Bacik J, Cheung A, Spriggs DR,. Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 2005; 104: 1497-1504. (Pubitemid 41356165)
8. Bachelot T, Ray-Coquard I, Catimel G, et al. Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials. Ann Oncol 2000; 11: 151-156. (Pubitemid 30148727)
9. Han C, Braybrooke JP, Deplanque G, et al. Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents. Br J Cancer 2003; 89: 1166-1171. (Pubitemid 37363397)
10. Lawrence YR, Vikram B, Dignam JJ, et al. NCI-RTOG Translational Program Strategic Guidelines for the Early-Stage Development of Radiosensitizers. J Natl Cancer Inst 2013; 105: 11-24.
11. Normolle D, Lawrence T,. Designing Dose-Escalation Trials With Late-Onset Toxicities Using the Time-to-Event Continual Reassessment Method. J Clin Oncol 2006; 24: 4426-4433. (Pubitemid 46630980)
12. Joffe S, Miller FG,. Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol 2006; 24: 2987-2990. (Pubitemid 46638930)
13. Jain RK, Lee JJ, Hong D, et al. Phase I oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clin Cancer Res 2010; 16: 1289-1297.
14. Giro C, Berger B, Bolke E, et al. High rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: results of a survey in EORTC institutes. Radiother Oncol 2009; 90: 166-171.
15. Budach W, Bolke E, Homey B,. Severe Cutaneous Reaction during Radiation Therapy with Concurrent Cetuximab. N Engl J Med 2007; 357: 514-515. (Pubitemid 47204904)
16. Levy A, Hollebecque A, Bourgier C, et al. Targeted therapy-induced radiation recall. Eur J Cancer 2013; 49: 1662-1668.
17. Real FX, Krown SE, Nisce LZ, Oettgen HF,. Unexpected toxicity from radiation therapy in two patients with Kaposi's sarcoma receiving interferon. J Biol Response Mod 1985; 4: 141-146. (Pubitemid 15101416)
18. Inoue T, Kinoshita H, Komai Y, et al. Two cases of gastrointestinal perforation after radiotherapy in patients receiving tyrosine kinase inhibitor for advanced renal cell carcinoma. World J Surg Oncol 2012; 10: 167.
19. Kelly PJ, Dinkin MJ, Drappatz J, O'Regan KN, Weiss SE,. Unexpected late radiation neurotoxicity following bevacizumab use: a case series. J Neurooncol 2011; 102: 485-490.
20. Onal C, Abali H, Koc Z, Kara S,. Radiation recall pneumonitis caused by erlotinib after palliative definitive radiotherapy. Onkologie 2012; 35: 191-194.
21. Arakawa H, Johkoh T, Sakai F, Kusumoto M, Hataji O, Taguchi O,. Exacerbation of radiation fibrosis with erlotinib: another pattern of radiation recall phenomenon. Jpn J Radiol 2011; 29: 587-589.
22. Lind JS, Senan S, Smit EF,. Pulmonary toxicity after bevacizumab and concurrent thoracic radiotherapy observed in a phase I study for inoperable stage III non-small-cell lung cancer. J Clin Oncol 2012; 30: e104-108.
23. Spigel DR, Hainsworth JD, Yardley DA, et al. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 2010; 28: 43-48.
24. Gore E, Currey A, Choong N,. Tracheoesophageal fistula associated with bevacizumab 21 months after completion of radiation therapy. J Thorac Oncol 2009; 4: 1590-1591.
25. See AP, Zeng J, Tran PT, Lim M,. Acute toxicity of second generation HIV protease-inhibitors in combination with radiotherapy: a retrospective case series. Radiat Oncol 2011; 6: 25.
26. Bratland A, Dueland S, Hollywood D, Flatmark K, Ree AH,. Gastrointestinal toxicity of vorinostat: reanalysis of phase 1 study results with emphasis on dose-volume effects of pelvic radiotherapy. Radiat Oncol 2011; 6: 33.
27. Foote RL, Kasperbauer JL, Okuno SH, et al. A pilot study of high-dose intraarterial cisplatin chemotherapy with concomitant accelerated radiotherapy for patients with previously untreated T4 and selected patients with T3N0-N3M0 squamous cell carcinoma of the upper aerodigestive tract. Cancer 2005; 103: 559-568.