Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

NRG Oncology

Conditions:

Cervical Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...

Detailed Description

OBJECTIVES: Primary * To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with hig...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
  • Positive pelvic nodes
  • Positive parametrium
  • Positive para-aortic nodes that have been completely resected and are positron emission tomography (PET)/computed tomography (CT) scan-negative
  • PET only required if positive para-aortic nodes during surgery
  • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
  • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
  • Para-aortic and pelvic node sampling required
  • 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
  • No gross residual disease
  • No neuroendocrine histology
  • No distant metastases
  • PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelets ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 4,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
  • Alkaline phosphatase normal
  • Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥ 350/mm³ within the past 14 days
  • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
  • Coagulation defects
  • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior systemic chemotherapy for the current cervical cancer
  • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields

Exclusion

    Key Trial Info

    Start Date :

    September 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 4 2025

    Estimated Enrollment :

    236 Patients enrolled

    Trial Details

    Trial ID

    NCT00980954

    Start Date

    September 1 2009

    End Date

    September 4 2025

    Last Update

    December 31 2025

    Active Locations (125)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 32 (125 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Providence Hospital

    Mobile, Alabama, United States, 36608

    3

    Providence Alaska Medical Center

    Anchorage, Alaska, United States, 99508

    4

    Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, United States, 85381