A randomized trial of pelvic radiation therapy versus no further therapy in selected patients with stage IB carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy:
A Gynecologic Oncology Group Study

Disease site

Cervix

Publication month/year

May, 1999

Study question

To determine whether postoperatice pelvic radiotherapy following radial hysterectomy and pelvic node dissection would reduce the rate of reoccurrence and decrease mortality in Stage IB cancer patients.

Type of study

Randomised controlled trial (RCT)

Interventions compared

Pelvic radiotherapy (RT) vs no further treatment (NFT)

Experimental arm (Intervention)

Radiotherapy (RT)

Control arm

No further treatment (NFT)

Primary outcome

Recurrence-free interval

Inclusion criteria
  • Primary stage IB (squamous, adenosquamous carcinoma or adenocarcinoma)
  • Treated with standard radical hysterectomy and bilateral pelvic lymphadenectomy
  • Negative lymph nodes
  • At least two of the following risk factors:
    1. large clinical tumor diameter
    2.  >1/3 deep stromal invasion
    3. Capillary lymphatic space involvement 
  • Normal blood counts, normal liver and kidney functions.
  • Absence of genitourinary tract abnormalities 
  • Absence of intercurrent diseases
Exclusion criteria
  • Lack of documentation of high-risk criteria 
  • Wrong stage
  • Inadequate surgery
  • Inadequate pathology for review
  • Not undergoing an intravenous pyelogram or CT
Results
Radiotherapy No further treatment
Randomised 137 140
Cancer recurrence 15.3% 27.9 %
Local (vaginal/pelvic) 13.1% 19.3%
Distant 2.2% 7.1%
Mortality 13.1% 21.4%
Adverse effects (Grades3-4) 7.0% 2.1%
Urological adverse effects 3.1% 1.4%
Hematological adverse effects 2.3% 0.7%
Gastrointestinal adverse effects 3.1% 0%
Neurological adverse effects 0.8% 0%
Other results
  • 47% reduction in risk of reoccurrence (relative risk 0.53 and p=0.008, one tail ) among the RT group
  • Recurrence-free rates at 2 years of 88% versus 79% in RT and NFT groups, respectively
  • The relative mortality rate is estimated at 0.64 indicating 26% less mortality in the radiation group
Conclusions

Adjunctive radiotherapy is beneficial for Stage 1 cervical cancer patients with clinical-pathological risk factors for recurrence other than positive nodes at the cost of 6% grade 3/4 adverse events versus 2/1% in the NFT group.

Study limitations
  • Lost to follow up (especially among the radiation therapy group)
  • Estimation of tumor diameter by palpation is subjective 
  • Evaluation of capillary lymphatic space involvement is subjectiv.
  • There were some imbalances in the distribution of the patients based on the prognostic factor make-up of each group.
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