Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2019/04/018382
- Lead Sponsor
- RG National Research Group Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including both para-aortic and pelvic node sampling for cervical carcinoma within 70 days prior to study entry.
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:
2.1 Positive pelvic nodes
2.2 Positive parametrium
2.3 Positive para-aortic nodes- completely resected, 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]
3.1 History/physical examination within 56 days prior to study entry
3.2 Contrast-enhanced imaging of the abdomen and pelvis by either CT, MRI, or PET-CT (whole body) within 90 days prior to registration. (NOTE: whole body PET-CT is preferred)
3.3 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 per Section 3.1.3.2).
4. Zubrod performance status 0-1.
5. CBC/differential obtained 14 days prior to study entry, with adequate bone marrow function defined as follows:
5.1 Absolute neutrophil count (ANC) >= 1,800 cells/mm3
5.2 Platelets >= 100,000 cells/mm3
5.3 Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable.)
5.4 White blood cell count >= 4000 cells/mm3
6. Adequate hepatic and renal function defined as follows:
6.1 Serum creatinine <= 1.5 mg/dL within 14 days prior to study entry
6.2 Bilirubin <= 1.5 times normal 14 days prior to study entry
6.3 Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry
6.4 AST/SGOT within upper limits of institutional normal within 14 days prior to study entry
6.5 Patients with known HIV positive must have a CD4 cell count be >= 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol.)
7. Patient must provide study-specific informed consent prior to study entry.
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:
5.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
5.2 Transmural myocardial infarction within the last 6 months
5.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
5.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
5.5 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in disease free survival of early cervix cancer.Timepoint: 4 Years
- Secondary Outcome Measures
Name Time Method Adverse events, Associations between tumor molecular signatures, from fixed tissue, and outcomes such as <br/ ><br>adverse events, disease free survival and overall survival,Associations between secreted factors from serum and plasma with adverse events or outcome, Associations between SNPs in genes from buffy coat and a genetic predisposition to tumor formation itself or a response to cytotoxic therapyTimepoint: during and after treatment completion.;Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4, QOL as assessed by FACT-Cx & FACIT-DTimepoint: At 6,12,24 months;Overall SurvivalTimepoint: 4 years