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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

Phase 3
18 Years
Open (Enrolling)
Cervical Cancer

Thank you

Trial Information

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



- 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.


- 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

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.

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome 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.

Safety Issue:


Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:

RTOG 0724



Start Date:

September 2009

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • stage IA cervical cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • Uterine Cervical Neoplasms



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