MDACC Study Summary RTOG0418

Study Summary
No. RTOG0418:.......Cervix; Endometrial; Gynecology......Anuja Jhingran......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG0418

Study Title:	A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma

Physician

New Patient Referral



Name:	Anuja Jhingran	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-6888 Contact us about clinical trials

General Information



Disease Group:	Cervix Endometrial Gynecology	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Follow-up will be performed four weeks post completion of IMRT and then every 3 months during the first two years; every 6 months during years 3-5; then annually. 3 month scan post CTX/RT; then every 6 months for 2 years; then annually for 5 years.

Treatment Agents:	Cisplatin Radiation	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to test whether the use of an advanced way to give radiation treatments called intensity-modulated radiation therapy (IMRT) can spare normal tissue, including small bowel and large bowel, from radiation. Quality-of-life will also be studied to see if using this new way to give radiation can improve quality-of-life after radiation.

Study Objectives / Outcomes

1. To determine the transportability of IMRT to a multi-institutional setting.
2. To test the hypothesis that there is a reduction in short-term bowel injury with this regimen compared to standard treatments
3. To assess adverse events related to this regimen.
4. To estimate the rates of local-regional control, distant metastisis, disease-free and overall survival.
5. To evaluate chemotherapy compliance with this regimen for the cervical carcinoma patients.

Study Status Information



Study Activation / Registration Date:	07/12/2006

IRB Review and Approval Date:	06/21/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	92

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or laparoscopic-assisted vaginal hysterectomy) for carcinoma of the cervix or endometrium within 7 weeks prior to study entry. Patients with endometrial carcinoma must also have had a bilateral salpingo-oophorectomy.

2) Patients must require postoperative radiation therapy (endometrial cancer) or chemo/radiation therapy (cervical cancer).

3) Endometrial Cancer: Patients with stage IB, grade 3, IC grade 1-3, IIA or IIB requiring post-operative pelvic radiation therapy are eligible for this trial.

4) Endometrial Cancer: Patients with unstaged (no lymph node dissection or sampling) Stage IB, grade 2 are eligible for this trial.

5) Endometrial Cancer: Patients with Stage IIIC, pelvic lymph node positive only, para-aortic nodes sampled and negative and not going to receive chemotherapy are eligible for this trial.

6) Patients with cervical cancer initially treated with a radical hysterectomy and lymph node dissection that require post-operative pelvic radiation therapy are eligible for this study.

7) Patients with cervical cancer treated with a simple hysterectomy with negative margins and negative nodes by CT/MRI/PET-CT are eligible for this study.

8) Cervical Cancer: Post-radical hysterectomy - if the patient has positive pelvic nodes (negative para-aortic nodes) they are eligible for this study.

9) Cervical Cancer: Post-radical hysterectomy - if the patient has microscopic parametrial invasion and negative margins they are eligible for this study.

10) Cervical Cancer: Post-radical hysterectomy - if the patient qualifies by having met the Sedlis criteria for post-surgery for pelvic radiation therapy they are eligible for this study. The patient must have two of the following risk factors for this criterion: a. 1/3 or more stromal invasion b. lymph-vascular space invasion c. large clinical tumor diameter (greater than or equal to 4 cm)

11) Age greater than or equal to 18

12) Zubrod performance status 0-2

13) Hemoglobin greater than or equal to 8.0 g/dl (Note: The use of transfusion or other interventions to achieve Hg greater than or equal to 8.0 g/dl is acceptable.) (endometrial and cervix patients). Patients with adequate bone marrow, renal and hepatic function (all labs are to be obtained less than or equal to 14 days prior to registration). WBC greater than or equal to 4,000/mm^3 (cervix patients only); ANC greater than or equal to 1,800 cells/mm^3 (cervix patients only); Platelets greater than or equal to 100,000 cells/mm^3 (cervix patients only).

14) Serum Creatinine less than or equal to 2.0 mg/dl and calculated creatinine clearance greater than or equal to 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockroft-Gault formula: (140-age) x (ideal weight as kg) / (Serum Creatinine x 72) x 0.85; AST, bilirubin, alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded.

15) Prior to registration CT/MRI/PET-CT of abdomen/pelvis, for initial radiological staging, must be performed pre- or post-surgery (Cervix patients only)

16) Chest x-ray or chest CT must be performed within 8 weeks prior to study entry.

17) The patient must sign a study-specific informed consent.

Exclusion Criteria:

1) Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.

2) Patients with histology consisting of papillary serous, clear cell or neuroendocrine (either large or small cell), endometiral stromal sarcoma, leiomysarcoma or malignant mullerian mixed tumer.

3) Patients who exceed the weight/size limits of the treatment table or CT scanner.

4) mental status changes or bladder control problems that make the patient unable to comply with the bladder-filling instructions.

5) Patients with evidence of metastatic disease outside of the pelvis.

6) Patients with microscopic involvement of the resection margin (<3 mm) will be excluded.

7) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.

8) Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.

9) Patients with active inflammatory bowel disease

10) Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antiobiotics at the time of registration.

11) Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at time of registration.

12) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however that laboratory test coagulation parameters are not required for entry into this protocol.

13) Acquired Immune Dificiency Syndrom (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.

14) Cervical cancer patients with prior allergic reactions to cisplatin will be excluded.

15) Cervical cancer patients with prior treatment with platinum-based chemotherapy.

16) Transmural myocardial infarction within the last 6 months.

17) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Links

Registration Number: NCT00331760
Study Information on Clinical Trials Registry (clinicaltrials.gov)