Know Cancer

or
forgot password

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
N/A
Open (Enrolling)
Female
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


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.

Inclusion Criteria


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

Type of Study:

Interventional

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:

No

Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG 0724

NCT ID:

NCT00980954

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Rush University Medical CenterChicago, Illinois  60612-3824
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
UMDNJ University HospitalNewark, New Jersey  07103
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
OSF St. Francis Medical CenterPeoria, Illinois  61637
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Treatment CenterWooster, Ohio  44691
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Flower Hospital Cancer CenterSylvania, Ohio  43560
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Seattle Cancer Care AllianceSeattle, Washington  98109
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Mercy General HospitalSacramento, California  95819
Cancer Care Center, IncorporatedSalem, Ohio  44460
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
Saint Helena HospitalSaint Helena, California  94574
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
Nebraska Medical CenterOmaha, Nebraska  68198
Robinson Radiation OncologyRavenna, Ohio  44266