RTOG 1203 A RANDOMIZED PHASE III STUDY OF STANDARD VS. IMRT PELVIC RADIATION FOR POST-OPERATIVE TREATMENT OF ENDOMETRIAL AND CERVICAL CANCER (TIME-C)

Study ID
STU 022013-006

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Ying Dong
214-645-8519
ying.dong@utsouthwestern.edu

Principal Investigator
Kevin Albuquerque

Summary

evidence also suggests that iMRT results in similar cancer outcomes as conventional WPRT. a
study published from Washington university comparing iMRT to conventional WPRT in patients
with locally advanced cervix cancer showed no statistically significant difference in recurrencefree
survival between the two groups, and actually better cause-specific and overall survival in the
iMRT group (Kidd 2010). RToG 0418 showed excellent cancer outcomes with iMRT: two year
overall survival was 95% for both cervical and endometrial cancer patients, and two year locoregional
failure rates for cervical and endometrial cancer patients were 11% and 7%, respectively
(unpublished data). These results are comparable to historical data for conventional WPRT which
have shown overall survival rates of 81% and 85-92%, and loco-regional failure rates of 12-20%
and 2-5%, for cervical and endometrial cancer, respectively (Sedlis 1999, Scholten 2005, Keys
2004, nout 2010, Peters 2000). These findings suggest that pelvic iMRT is safe and provides at
least equivalent rates of pelvic disease control. To evaluate this issue carefully on this study, we
will compare clinical outcomes including local recurrence, progression-free survival or overall
survival with iMRT to standard pelvic RT.

Participant Eligibility

1. Is there a pathologically proven diagnosis of endometrial or cervical cancer
2. Has the patient undergone a hysterectomy (total abdominal hysterectomy, vaginal
hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for
carcinoma of the cervix or endometrium within 49 days prior to registration?.
3. Has appropriate staging for protocol entry been performed, based upon the following
minimum diagnostic workup?

* History/physical examination within 45 days prior to registration
. CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant
metastasis, performed pre- or post-surgery within 90 days prior to registration
. Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
4. Zubrod Performance Status 0-2
5. Is the patient >= 18 years of age?
6. Has a CBC/differential been obtained within 14 days prior to registration on study, with
adequate bone marrow function defined as follows?

* Absolute neutrophil count (ANC) >= 1,500 cells/mm3;

* Platelets >= 100,000 cells/mm3;

* Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to
achieve Hgb >= 8.0 g/dl is acceptable.)
For patients receiving chemotherapy:
7. Has the following laboratory been done within 14 days prior to registration?:

* Serum Creatinine <= 1.5 mg/dl and calculated creatinine clearance >= 50 cc/min
Both tests must be within these limits. The creatinine clearance should be
calculated using the Cockroft-Gault formula: (See Section 7.3.1)

* AST <= 2 x ULN

* Bilirubin <= 2 x ULN

* Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded
8.Does the patient meet criteria for one of the following four questions:
For patients with endometrial cancer to be treated without weekly cisplatin:
Does the patient have the following pathology findings? :

* <50% myometrial invasion, grade 3 adenocarcinoma without uterine serous
carcinoma (USC) or clear cell histology

* >=50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell
histology
For patients with endometrial cancer to be treated with or without weekly cisplatin at the treating physician's discretion:
Does the patient have one of the following pathology findings?

* >= 50% myometrial invasion, grade 3 including USC and clear cell carcinoma.

* FIGO 2009 stage II endometrial cancer of any grade including USC and clear cell
carcinoma.

* FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes sampled
and negative) including USC and clear cell carcinoma.
For patients with cervical cancer to be treated with or without weekly cisplatin at the
treating physician[Single Quote]s discretion:
Does the patient have two of the following risk factors after radical hysterectomy?

* 1/3 or more stromal invasion

* Lymph-vascular space invasion

* Large clinical tumor diameter (> 4 cm)
or
Has the patient with cervical cancer been treated with a simple hysterectomy with
negative margins and negative nodes by CT/MRI/PET-CT?
For patients with cervical cancer to be treated with weekly cisplatin:
Does the patient have any of the following criteria following radical hysterectomy?

* Positive resected pelvic nodes (para-aortic nodes sampled and negative)

* Microscopic parametrial invasion with negative margins
9. Has the patient signed the study specific informed consent prior to study entry?
10. Is the patient willing and able to complete the bowel and urinary domains of the EPIC
prior to registration ?