GOG 120 Study
Concurrent Cisplatin-Based Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer

Disease site

Cervix

Publication month/year

April 1999

Study question

Do regimens of radiotherapy and chemotherapy that contain cisplatin improve the rates of survival and progression-free survival among women with locally advanced cervical cancer?

Type of study

Randomised controlled trial (RCT)

Interventions compared

EBRT +

  • Cisplatin alone (C)
  • Cisplatin plus Fluorouracil & Hydroxyurea (CFH)
  • Hydroxyurea alone (H)
Experimental arm (Intervention)

Two interventions;

  1. Radiotherapy combined with Cisplatin alone
  2. Radiotherapy with a combination of Cisplatin plus Fluorouracil & Hydroxyurea



Control arm

Radiotherapy combined with Hydroxyurea alone

Primary outcome
  • Overall survival
  • Progression-free survival
Secondary outcome
  • Local progression
  • Frequency of lung metastases
  • Local recurrences
  • Distant recurrence
  • Adverse effects
Inclusion criteria
  • Untreated cervical carcinoma  FIGO stage IIB-IVB (bladder/rectal mucosa). 
  • Good PS
Exclusion criteria
  • Disease outside the pelvis and those with metastasis to paraaortic lymph nodes or intraperitoneal disease
Results
Cisplatin alone Cisplatin plus Fluorouracil & Hydroxyurea Hydroxyurea alone
Randomised (n)
176
173
177
progression-free survival rate
109
173
73
Progression-free survival at 2 years (n)
67
64
47
Progression-free survival at 4 years (n)
27
35
20
  • There is significant improvement in survival rates in using cisplatin alone and using cisplatin plus fluorouracil plus hydroxyurea
  • EBRT+CFH was associated with the highest toxcity
Conclusions
  • Superiority of radiotherapy and chemotherapy either with Cisplatin alone or with Cisplatin, Fluorouracil, and Hydroxyurea in patients with locally advanced cervical cancer
  • Cisplatin alone was less toxic than treatment with the three-drug regimen.
Study limitations
  • Low numbers in treatment arms
Additional resources
Reviewer name
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