Trial record 1 of 1 for:    RTOG 0724
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Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00980954
First received: September 18, 2009
Last updated: May 29, 2014
Last verified: May 2014

September 18, 2009
May 29, 2014
September 2009
August 2021   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: From randomization to date of first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Analysis occurs after 43 disease-free survival failure events on Cisplatin/RT Arm. ] [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00980954 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4 [ Time Frame: From completion of concurrent chemoradiation to 12 months. ] [ Designated as safety issue: No ]
  • Quality of life as measured by FACT-Cx and FACIT-D [ Time Frame: From completion of concurrent chemoradiation to 12 months. ] [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4 [ Designated as safety issue: No ]
  • Quality of life as measured by FACT-Cx and FACIT-D [ Designated as safety issue: No ]
  • Associations between tumor molecular signatures from fixed tissue samples and outcomes, such as adverse events, disease-free survival, and overall survival [ Designated as safety issue: No ]
  • Associations between secreted factors from serum and plasma samples and adverse events or outcome [ Designated as safety issue: No ]
  • Associations between SNPs in genes from buffy coat and a genetic predisposition to tumor formation itself or a response to cytotoxic therapy [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
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

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 dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

OBJECTIVES:

Primary

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

Secondary

  • To evaluate adverse events.
  • To evaluate overall survival.
  • To evaluate quality of life.
  • To evaluate chemotherapy-induced neuropathy.
  • To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy (IMRT) with respect to toxicity and local control.
  • To collect fixed tissue samples 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 samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to 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.

OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - [standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.

NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

  • Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.

Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies.

After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Cancer
  • Drug: carboplatin
    Given IV
  • Drug: cisplatin
    Given IV
  • Drug: paclitaxel
    Given IV
  • Experimental: Arm I: Cisplatin/Radiation Therapy
    Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.
    Intervention: Drug: cisplatin
  • Experimental: Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
    Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: carboplatin
    • Drug: cisplatin
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
Not Provided
August 2021   (final data collection date for primary outcome measure)

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 PET/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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Hong Kong,   Korea, Republic of
 
NCT00980954
RTOG 0724, CDR0000654709, NCI-2011-01973
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Anuja Jhingran, MD M.D. Anderson Cancer Center
Radiation Therapy Oncology Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP