GOG 120 Study
Concurrent Cisplatin-Based Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer
Disease site
Cervix
Pubmed link
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;
- Radiotherapy combined with Cisplatin alone
- 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