Chemoradiation Trials

CHEMOTHERAPY

Neoadjuvant Chemotherapy
7 studies have shown no advantage to neoadjuvant chemo

Sardi Gyn Oncol 67:61, 1997 looked at neoadjuvant chemo prior to surgery vs surgery alone for IB > 2 cm demonstrating a better resectibility rate and survival

Concurrent Chemotherapy Trials

Trials Eligibility Randomization Result Comments
Definitive Chemoradiation
GOG 85/ SWOG 8695
(Whitney)
IIB to IVA & PAN(-) by surg RT+ 5FU/cisplatin vs RT + HU OS 55% (5-FU/cisplatin)
vs 43% (HU)
GOG 120
(Rose)
IIB to IVA & PAN(–) by surg RT : WBRT + T&O to 81 Gy
1) Cisplatin 40 mg/m2 weekly
2) 5-FU/C/H
3) Hydroxyurea
65%(cis-platin arms) to 47%
NCI-C IIB-IVA, IB2/IIA (> 5cm), or Pelvic LN+ (same as Morris) WPRT 45 Gy + T&O (35 GY) vs same + C 40 mg/m2 Qwk. OS-5 58% vs 62% (NS) No surgical staging of the patients. 51 days to treatment completion vs Whitney and Rose 64 and 62 days.
Elective Nodal: Chemoradiation
RTOG 9001
(Morris)
IIB to IVA, IB2/IIA (> 5cm), or Pelvic LN+ EFRT + T&O x 2 to 85 Gy vs. WPRT + T&O x 2 to 85 Gy + Chemo (C 75 mg Q3 wk) OS-8 67% vs 41% favoring chemoRT Non-sig PA node failure 8% vs 4% favoring RT alone
Pre-operative Chemoradiation
GOG 123
(Keys)
IB2 only WPRT and T&O to 75 Gy Simple Hysterectomy vs same + C 40 mg/m2 Q wk. OS-3 83% vs 74% Pre-op CRT Trial Chemo improved LC translated into OS adv. Thus thought is to increase RT dose not surgery
Post-op Chemoradiation
SWOG 8797 /GOG 109
(Peters)
IA2-IB2A, Pelvic LN+, Margins+, or Parametrial+ § WPRT 50 Gy + PANRT 45 Gy (if common iliac+) vs. same with chemo 5-FU & C 75 mg/m2 q 3 wks. OS-4 81% vs 71% Post-op CRT trial. Most beneficial to > 2 cm tumors and => 2 LN+.
Post-op Radiation
GOG 92/ RTOG 8706[1] IB with 2+ negative features† WPRT 46-50.4 Gy vs Observation • OS (NS)
Recurrences 17.5% vs 30.7% (SIG)
reduction seen in for both local and distal recurrences

§: GOG 109 Risk factors are outside of cervix
†: GOG 92 Risk factors are confined to cervix
for details see == Post-Operative Treatment ==

Bibliography
1. MARVIN ROTMAN, M.D., ALEXANDER SEDLIS, M.D., MARION R. PIEDMONTE, M.A., BRIAN BUNDY, PH.D., SAMUEL S. LENTZ, M.D., LAILA I. MUDERSPACH, M.D., AND RICHARD J. ZAINO, M.D. A PHASE III RANDOMIZED TRIAL OF POSTOPERATIVE PELVIC IRRADIATION IN STAGE IB CERVICAL CARCINOMA WITH POOR PROGNOSTIC FEATURES: FOLLOW-UP OF A GYNECOLOGIC ONCOLOGY GROUP STUDY. Int. J. Radiation Oncology Biol. Phys., Vol. 65, No. 1, pp. 169–176, 2006
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