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.
To evaluate if the addition of Cisplatin (with or without fluorouracil) chemotherapy to standard pelvic radiation therapy could improve the progression-free survival and overall survival of patients at high risk for relapse after primary radical hysterectomy
Type of study
Randomised controlled trial (RCT)
Addition of chemotherapy vs Standard therapy alone
Experimental arm (Intervention)
Chemotherapy, in addition to standard therapy (Radiotherapy)
Standard therapy (Radiotherapy) devoid of chemotherapy
- Progression-free survival
- Overall survival
- Toxicity in the experimental arm
- Patients undergoing a type 3 hysterectomy with pelvic lymphadenectomy for carcinoma of the cervix.
- Stage of carcinoma
- IA2, IB, or IIA
- Patients having squamous carcinoma, adenocarcinoma or an adenosquamous carcinoma with histologically confirmed positive pelvic lymph nodes, positive parametrial involvement or positive surgical margin.
|Intervention arm||Control arm|
|Received treatment||Chemotherapy + Radiotherapy||Radiotherapy Alone|
|Median follow-up period||42 months||42 months|
|Estimated 4-year progression free survival||80%||63%|
|Overall 4-year survival||81%||71%|
|Toxicity (Grade 4)||21 (17.2%)||4 (3.5%)|
|Pelvic and extra pelvic recurrences||40||78|
Higher numbers of chemotherapy courses are favourably associated with both progression-free survival and overall survival.
- Patients receiving both chemotherapy and radiation therapy had a statistically significant improvement in progression free survival, overall survival and decreased recurrence rates
- Patients receiving both chemotherapy and radiation therapy display a greater degree of toxicity, which must be considered into treatment decision
- Could not assess if the effect of chemotherapy is independent of radiotherapy due to inherit characteristics of the studied sample (i.e poor tolerance to chemotherapy)
- The statistical boundaries for rejecting the study’s null hypothesis were crossed out