Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials

Journal of Clinical Oncology

Volumn 24, Issue 24, 2006, Pages 3871-3879

  Buckner, Jan C ^a   Ballman, Karla V ^a   Michalak, John C ^a   Burton, Gary V ^a   Cascino, Terrence L ^a   Schomberg, Paula J ^a   Hawkins, Roland B ^a   Scheithauer, Bernd W ^a   Sandler, Howard M ^a   Marks, Randolph S ^a   O'Fallon, Judith R ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARMUSTINE; CISPLATIN; ALKYLATING AGENT; ANTINEOPLASTIC AGENT;

ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DERMATITIS; DRUG DELIVERY SYSTEM; FEMALE; GLIOBLASTOMA; HEADACHE; HEARING LOSS; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; INTERMETHOD COMPARISON; LETHARGY; MAJOR CLINICAL STUDY; MALE; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OTOTOXICITY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SENSORY NEUROPATHY; THROMBOCYTOPENIA; VOMITING; ADJUVANT CHEMOTHERAPY; ADJUVANT THERAPY; DISEASE FREE SURVIVAL; MIDDLE AGED; MULTICENTER STUDY; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME; UNITED STATES;

ADULT; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARMUSTINE; CHEMOTHERAPY, ADJUVANT; CISPLATIN; DISEASE-FREE SURVIVAL; FEMALE; GLIOBLASTOMA; HUMANS; MALE; MIDDLE AGED; PROGNOSIS; RADIOTHERAPY, ADJUVANT; SURVIVAL ANALYSIS; TREATMENT OUTCOME; UNITED STATES;

EID: 33748454110     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.04.6979     Document Type: Article

References (38)

1. Al-Sarraf M, LeBlanc M, Giri PG, et al: Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized Intergroup study 0099. J Clin Oncol 16:1310-1317, 1998
2. Lin JC, Jan JS, Hsu CY, et al: Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: Positive effect on overall and progression-free survival. J Clin Oncol 21:631-637, 2003
3. Chan AT, Leung SF, Ngan RK, et al: Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst 97:536-539, 2005
4. Brizel DM, Albers ME, Fisher SR, et al: Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med 338:1798-1804, 1998
5. Adelstein DJ, Saxton JP, Lavertu P, et al: A phase III randomized trial comparing concurrent chemotherapy and radiotherapy with radiotherapy alone in resectable stage III and IV squamous cell head and neck cancer: Preliminary results. Head Neck 19:567-575, 1997
6. Calais G, Alfonsi M, Bardet E, et al: Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst 91:2081-2086, 1999
7. Taylor SG 4th, Murthy AK, Vannetzel JM, et al: Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol 12:385-395, 1994
8. Herskovic A, Martz K, Al-Sarraf M, et al: Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 326:1593-1598, 1992
9. Sause W, Kolesar P, Taylor SI, et al: Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer: Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. Chest 117:358-364, 2000
10. Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al: Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 18:1606-1613, 2000
11. Keys HM, Bundy BN, Stehman FB, et al: Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med 340:1154-1161, 1999
12. Newton HB, Page MA, Junck L, et al: Intra-arterial cisplatin for the treatment of malignant gliomas. J Neurooncol 7:39-45, 1989
13. Stewart DJ, Wallace S, Feun L, et al: A phase I study of intracarotid artery infusion of cis-diamminedichloroplatinum(II) in patients with recurrent malignant intracerebral tumors. Cancer Res 42:2059-2062, 1982
14. Feun LG, Wallace S, Stewart DJ, et al: Intracarotid infusion of cis-diamminedichloroplatinum in the treatment of recurrent malignant brain tumors. Cancer 54:794-799, 1984
15. Stewart DJ, O'Bryan RM, Al-Sarraf M, et al: Phase II study of cisplatin in recurrent astrocytomas in adults: A Southwest Oncology Group study. J Neurooncol 1:145-147, 1983
16. Khan AB, D'Souza JB, Wharam MD, et al: Cisplatin therapy in recurrent childhood brain tumors. Cancer Treat Rep 66:2013-2020, 1982
17. MacDonald DR, Cairncross JG, Rathbone MP: Cisplatinum chemotherapy for recurrent brain tumors. J Neurooncol 2:287, 1984 (abstr)
18. Dewit L: Combined treatment of radiation and cisdiamminedichloroplatinum (II): A review of experimental and clinical data. Int J Radiat Oncol Biol Phys 13:403-426, 1987
19. Douple EB: Platinum-radiation interactions. NCI Monogr 6:315-319, 1988
20. Rajkumar SV, Buckner JC, Schomberg PJ, et al: Phase I evaluation of pre-irradiation chemotherapy with BCNU and cisplatin and accelerated radiation therapy in patients with high grade glioma. J Neurosurg 44:67-73, 1999
21. Rajkumar SV, Buckner JC, Schomberg PJ, et al: Phase I and pharmacokinetic study of preirradiation chemotherapy with BCNU, cisplatin, etoposide, and accelerated radiation therapy in patients with high-grade glioma. Int J Radiat Oncol Biol Phys 42:969-975, 1998
22. Gilbert M, O'Neill A, Grossman S, et al: A phase II study of preradiation chemotherapy followed by external beam radiotherapy for the treatment of patients with newly diagnosed glioblastoma multiforme: An Eastern Cooperative Oncology Group study (E2393). J Neurooncol 47:145-152, 2000
23. Pocock SL, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:103-115, 1975
24. Peto R, Peto J: Asymptotically efficient rank invariant procedures (with discussion). J R Stat Soc A 135:185-207, 1972
25. Kaplan E, Meier P: Nonparametric estimation from incomplete observation. J Am Stat Assoc 53:457-481, 1958
26. Buckner JC, Michalak JC, Schomberg PJ: Phase III trial of BCNU plus cisplatin (CDDP) versus BCNU alone, and standard radiation therapy (SRT) versus accelerated radiation therapy (ART) in glioblastoma (GBM) patients: NCCTG/SWOG results. Proc Am Soc Clin Oncol 20:56a, 2001 (abstr 202)
27. Marshall NE, Ballman KV, Michalak JC, et al: Ototoxicity of cisplatin plus standard radiation therapy vs. accelerated radiation therapy in glioblastoma patients. J Neurooncol 77:315-320, 2006
28. Fine HA, Dear KB, Loeffler JS, et al: Meta-analysis of radiation therapy with and without adjuvant chemotherapy for malignant gliomas in adults Cancer 71:2585-2597, 1993
29. Stewart LA: Chemotherapy in adult high-grade glioma: A systematic review and meta-analysis of individual patient data from 12 randomised trials. Lancet 359:1011-1018, 2002
30. Grossman SA, O'Neill A, Grunnet M, et al: Phase III study comparing three cycles of infusional carmustine and cisplatin followed by radiation therapy with radiation therapy and concurrent carmustine in patients with newly diagnosed supratentorial glioblastoma multiforme: Eastern Cooperative Oncology Group Trial 2394. J Clin Oncol 21:1485-1491, 2003
31. Stewart DJ, Mikhael NZ, Nair RC, et al: Platinum concentrations in human autopsy tumor samples. Am J Clin Oncol 11:152-158, 1988
32. Stupp R, Mason WP, van den Bent MJ, et al: Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352:987-996, 2005
33. Yung WK, Albright RE, Olson J, et al: A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer 83:588-593, 2000
34. Brada M, Hoang-Xuan K, Rampling R, et al: Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse. Ann Oncol 12:259-266, 2001
35. Buckner JC: Factors influencing survival in high-grade gliomas. Semin Oncol 30:10-14, 2003
36. Buckner JC, Schomberg PJ, McGinnis WL, et al: A phase III study of radiation therapy plus carmustine with or without recombinant interferon-alpha in the treatment of patients with newly diagnosed high-grade glioma. Cancer 92:420-433, 2001
37. Taylor BV, Buckner JC, Cascino TL, et al: Effects of radiation and chemotherapy on cognitive function in patients with high-grade glioma. J Clin Oncol 16:2195-2201, 1998
38. Jaeckle KA, Ballman KV, Uhm J, et al: Comparison of survival endpoints in glioblastoma patients receiving or not receiving anticonvulsants and enzyme-inducing anticonvulsants in NCCTG trials. J Clin Oncol 13s, 2004 (suppl, abstr 1525)