GOG 263: Randomized Phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Study ID
STU 052012-032

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Annette Paulsen
214-648-2290
annette.paulsen@utsouthwestern.edu

Principal Investigator
David Miller

Summary

This study is designed as a randomized (allocation ratio is 1:1) Phase iii clinical trial of adjuvant RT (control arm) versus weekly cisplatin concurrent to RT in post-operative intermediate risk Stage i-iia cervical cancer patients. intermediate risk patient characterization is based on three post surgical prognostic factors namely, capillary
lymphatic space (CLS) involvement, stromal invasion and tumor size.5, 17, 40,41.

QoL assessment time points and Form SHQ (Smoking History) Questionnaire:
each patient will complete the QoL questionnaire at the following time points regardless of the amount of study therapy received.
T0: baseline, just prior to entry/randomization
T1: 3 weeks from planned (or actual) treatment start date
T2: 7 weeks from planned (or actual) treatment start date
T4: 36 weeks from planned (or actual) treatment start date

Regimen i (control arm):
Radiation Therapy:
(external pelvic standard radiation or iMRT)

Regimen ii (CRT arm):
Concurrent Cisplatin and Radiation Therapy
(external pelvic standard radiation or iMRT)
Cisplatin 40mg/m2 (max[?]70mg) iV over 1-2 hours weekly x 6 cycles with radiation therapy

We propose to bank Dna from whole blood to enable researchers to use genome-wide SnP and individual SnP analyses to identify SnPs that correlate with a variety of clinical measures, including but not limited to patient survival, recurrence of disease, response, and adverse events.

Participant Eligibility

3.11 Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy.
3.12 Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
3.121 Positive capillary-lymphovascular space involvement and one of the following:
Deep third penetration
Middle third penetration, clinical tumor >= 2 cm
Superficial third penetration, clinical tumor >= 5 cm
3.122 Negative capillary-lymphatic space involvement:
Middle or deep third penetration, clinical tumor >= 4
3.13 Patients must have adequate:
3.131 Hematologic function: ANC >= 1,500/mcl, platelets >= 100,000/mcl
3.132 Renal function: creatinine <= ULN or calculated creatinine clearance >= 60 mL/min.133 Hepatic function: bilirubin <= 1.5 x normal, alkaline phosphate and SGOT <= 3 x normal
3.14 GOG performance status 0, 1, 2.
3.15 Patients should not be randomized less than 3 weeks post-surgery but will not be
acceptable for randomization more than 8 weeks post-surgery.
3.16 Patients who have met the pre-entry requirements specified in Section 7.0.
3.17 Patients must have signed an approved informed consent and authorization permitting release of personal health information.
3.18 Patients must be >= 18 years of age. (06/13/2011)