MDACC Study Summary RTOG0724

Study Summary
No. RTOG0724:.......Cervix......Ann Klopp......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG0724

Study Title:	PHASE III RANDOMIZED STUDY OF CONCURRENT CHEMOTHERAPY AND PELVIC RADIATION THERAPY WITH OR WITHOUT ADJUVANT CHEMOTHERAPY IN HIGH-RISK PATIENTS WITH EARLY-STAGE CERVICAL CARCINOMA FOLLOWING RADICAL HYSTERECTOMY

Physician

New Patient Referral



Name:	Ann Klopp	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:	713-563-6830 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	RTOG Data Monitoring Committee RTOG

Phase of Study:	Phase III	Return Visit:	Standard for all cervical cancer patients treated at MDACC - every 3 months for the 1st 2 years, and than every 6 months for the next 3 years once a year.

Treatment Agents:	Carboplatin Cisplatin Paclitaxel Radiation	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Outpatient Basis


Description/ Intervention:	The goal of this clinical research study is to learn if the addition of carboplatin and paclitaxel to cisplatin and radiation can help to control cervical cancer better than cisplatin and radiation alone.

Study Objectives / Outcomes

To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after a radical hysterectomy.

Secondary Objectives:

To evaluate adverse events
Overall survival
Quality of life
Chemotherapy-induced neuropathy
To perform a post-hoc dose-volume evaluation between cases treated with standard radiation therapy (RT) and cases treated with Intensity-Modulated Radiation Therapy (IMRT) with respect to toxicity and local control
To collect fixed tissue to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.

To collect blood to:

Identify secreted factors from serum and plasma that may be associated with adverse events or outcome
Identify Single Nucleotide Polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/06/2010

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	N/A

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 radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry. [NOTE: If the patient did not have a para-aortic lymph node sampling / dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required. A negative pre or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection]

2) Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery: Positive pelvic nodes, Positive parametrium, Positive para-aortic nodes-completely resected, Positron Emission Tomography/Computerized Tomography (PET/CT) negative (PET only required if positive para-aortic nodes during surgery)

3) No distant metastases, based upon the following minimum diagnostic workup [NOTE: Patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible]: A. History/physical examination within 56 days prior to study entry; B. Contrast-enhanced imaging of the abdomen and pelvis by either CT, Magnetic Resonance Imaging (MRI), or PET-CT (whole body) within 90 days prior to registration. (NOTE: whole body PET-CT is preferred); C. Chest x-ray (PA and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT).

4) Zubrod performance status 0-1.

5) Age of greater than or equal to 18

6) Complete Blood Count (CBC)/differential obtained 14 days prior to study entry, with adequate bone marrow function defined as follows: A. Absolute neutrophil count (ANC) greater than or equal to 1,800 cells/mm^3; B. Platelets greater than or equal to 100,000 cells/mm^3; C. Hemoglobin greater than or equal to 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb greater than or equal to 10.0 g/dl is acceptable.); D. White blood cell count greater than or equal to 4000 cells/mm^3.

7) Adequate hepatic and renal function defined as follows: 1 Serum creatinine less than or equal to 1.5 mg/dL, 2 Bilirubin less than or equal to 1.5 times normal, 3 Alkaline phosphatase within upper limits of institutional normal, 4 ALT/SGPT and/or AST/SGOT within upper limits of institutional normal, 5 Patients with known HIV positive must have a CD4 cell count be greater than or equal to 350 cells/mm^3. All within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol.)

8) Patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria:

1) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

2) Patients can not have any neuroendocrine histology in pathology.

3) Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable.

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

5) Severe, active co-morbidity, defined as follows: A. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; B. Transmural myocardial infarction within the last 6 months; C. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry; D. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry; E. Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol.

6) Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin.

7) Patients who have gross residual disease or distant metastatic disease.

Links

Registration Number: NCT00980954
Study Information on Clinical Trials Registry (clinicaltrials.gov)