Table 1.
Characteristics of Included Studies
Trial | Accrual Period | Stage | Affected Para-Aortic Nodes Excluded? | Comparison | Concomitant CT (dose in mg/m2) | CT Schedule
|
RT (Gy) | BRT(Gy to point A) | RT Duration (days) | No. of Patients | |
---|---|---|---|---|---|---|---|---|---|---|---|
No. of Cycles | Frequency (weeks) | ||||||||||
Main analysis | |||||||||||
*Thomas (a)24 | 1987-1995 | Ib (>5 cm) to IVa | No | RT v CTRT | IV FU 32 mg/m2 | 2 | 3 | 50 | 40 | < 56 | 116 |
*Thomas (b)24 | 1987-1995 | Ib (>5 cm) to IVa | No | Hyperfractionated RT v hyperfractionated CTRT | IV FU 32 mg/m2 | 2 | 3 | 50 | 40 | < 56 | 118 |
*†Lorvidhaya (a)25 | 1987-1994 | IIb, IIIb to IVa | No | RT v CTRT | MMC 10 mg/m2 | 2 | 4 | 50 | 28 | 49-56 | 475 |
FU (oral) 4,200 mg | |||||||||||
*†Lorvidhaya (b)25 | 1987-1994 | IIb, IIIb to IVa | No | RT + Adj CT v CTRT + Adj CT | MMC 10 mg/m2, FU (oral) 4,200 mg | 2 | 4 | 50 | 28 | 49-56 | 451 |
3 | 4 | ||||||||||
Adj FU 5,600 mg (oral) | |||||||||||
Onishi44 | 1988-1998 | IIb to IV | No | RT v CTRT | CDDP1: 100 mg/m2 | 2 | 2-3 | 50 | 24 | 45-55 | 49 |
CDDP2: 50 mg/m2 | 3 | 1 | |||||||||
CBDCA: 100 mg/m2 | 6 | 1 | |||||||||
Roberts49 | 1991-2001 | Ib2, II to IVa | No | RT v CTRT | MMC 30 mg/m2 | 2 | 6 | IB2-IIB: 40‡ | 45-50 | Not specified | 248 |
III-IVA: 46‡ | 40-45 | ||||||||||
Peters8,46 SWOG8797 | 1991-1996 | Ia2 to IIa | No | S + RT v S + CTRT + CT | CDDP 70 mg/m2 | 4 | 3 | 49.3 | None | 42 | 268 |
FU 4,000 mg/m2 | |||||||||||
Pearcey43 | 1991-1996 | Ib-IIb (> 4 cm) III to IVa | No | RT v CTRT | CDDP 40 mg/m2 | 5 | 1 | 45 | 24-35 | 46-56 | 259 |
Keys6 GOG0123 | 1992-1997 | Ib (bulky) | Yes | S + RT v S + CTRT | CDDP 40 mg/m2 | 6 | 1 | 45 | 30 | < 70 | 374 |
*Chen (a)23 | 1993-1994 | IIb to III | No | RT v CTRT | CDDP 60 mg/m2 | 2 | 3 | 40 | 50 | 49 | 60 |
FU 1,500 mg/m2 | |||||||||||
VCR 2 mg/m2 | |||||||||||
*Chen (b)23 | 1993-1994 | IIb to III | No | RT + hyperthermia v CTRT + hyperthermia | CDDP 60 mg/m2 | 2 | 3 | 40 | 50 | 49 | 60 |
FU 1,500 mg/m2 | |||||||||||
VCR 2 mg/m2 | |||||||||||
Pras | 1995-1999 | Ib to IIa >4 cm | Yes | RT v CTRT | CDBCA 300 mg/m2 | 3 | 4 | 45 | 35 | > 56 | 54 |
IIb to IVa | FU 2,400 mg/m2 | ||||||||||
Leborgne | 1995-2004 | Ib2 to IVb | No | RT v CTRT | CDDP 80 mg/m2 | 2 | 4 | 40 | 42 | 40 | 340 |
FU 2,400 mg/m2 | |||||||||||
Garipagaoglu48 | 1996-1997 | IIb, IIIb | No | RT v CTRT | CDDP 120 mg/m2 | 2 | 3 | 46-50 | 20 | 61-62 | 44 |
Kantardzic45 | 1996-1999 | IIb to III | No | RT v CTRT + CT | CDDP 40 mg/m2 | 6 | 3 | 46 | 25-30 | 56-60 | 80 |
BLM 15 mg/m2 | 6 | 3 | |||||||||
*Lanciano (a)26 GOG0165 | 1997-1998 | IIb, IIIb, IVa | Yes | RT v CTRT | CDDP 40 mg/m2 | 6 | 1 | 45 | 30 (HDR) or 40 (LDR) | < 56 | 50 |
*Lanciano (b)26 GOG0165 | 1997-1998 | IIb, IIIb, IVa | Yes | RT v CTRT | FU 1,125 mg/m2 | 6 | 1 | 45 | 30 (HDR) or 40 (LDR) | < 56 | 51 |
Lal50 | 2000-2006 | II to IV | No | RT v CTRT | CDDP 35 mg/m2 | 5 | 1 | 50 | 18 | 63 | 180 |
Cikaric47 | 2002-2003 | IIb to IVa | No | RT v CTRT | CDDP 40 mg/m2 | 5 | 1 | 46 | 35 | 45 | 200 |
Sensitivity analysis | |||||||||||
Whitney10 GOG0085 | 1986-1990 | IIb to IVa | Yes | RT + HU v CTRT | CDDP 50 mg/m2 | 2 | 4 | 40.8 or 51 or 61.2 | 40 | < 70 | 388 |
FU 4,000 mg/m2 | 40 | ||||||||||
0 | |||||||||||
§Morris7,17 RTOG9001 | 1990-1997 | Ib to IIa (>4 cm or positive pelvic nodes) | Yes | RT v CTRT | CDDP 75 mg/m2 | 3 | 3 | 45 | 40 | < 56 | 403 |
FU 4,000 mg/m2 | |||||||||||
IIb to IVa | |||||||||||
*Rose (a)9 GOG0120 | 1992-1997 | IIb to IVa | Yes | RT + HU v CTRT | CDDP 40 mg/m2 | 6 | 1 | 40.8 or 51 or 61.2 | 40 | 70 | 384 |
40 | |||||||||||
0 | |||||||||||
*Rose (b)9 GOG0120 | 1992-1997 | IIb to IVa | Yes | RT + HU vCTRT + HU | CDDP 50 mg/m2 | 2 | 4 | 40.8 or 51 or 61.2 | 40 | 70 | 383 |
FU 4,000 mg/m2 | 40 | ||||||||||
HU (oral) 2 g/m2 | 1 | 6 | 0 |
Abbreviations: CT, chemotherapy; RT, radiotherapy; BRT, brachytherapy; CTRT, chemoradiotherapy; IV, intravenous; FU, fluorouracil; MMC, mitomycin; Adj, adjuvant; CDDP, cisplatin; CDBCA, carboplatin; S, surgery; VCR, vincristine; BLM, bleomycin; HDR, high-dose rate; LDR, low-dose rate; HU, hydroxyurea; GOG, Gynecologic Oncology Group; RTOG, Radiation Therapy Oncology Group.
Three-arm and four-arm trials were analyzed as two separate trials.
After 673 patients were randomly assigned, FU was given 300 mg/day (oral) Monday through Friday for duration of external-beam radiotherapy.
With or without 8- to 10-Gy parametrial boost.
Extended-field external-beam radiotherapy (to para-aortic nodes) given on the control arm.