Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01101451
First received: April 9, 2010
Last updated: March 7, 2014
Last verified: March 2014

April 9, 2010
March 7, 2014
April 2010
December 2020   (final data collection date for primary outcome measure)
Recurrence-free survival [ Time Frame: From protocol registration to date of first documented recurrence, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
Estimated according to the method of Kaplan and Meier and compared using the one sided log-rank test.
Recurrence-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01101451 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: From entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol, assessed up to 5 years ] [ Designated as safety issue: No ]
    Estimated according to the method of Kaplan and Meier and compared using the one sided log-rank test.
  • Local control [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Assessed with Exact Logistic Regression adjusted known prognostic factors.
  • Adverse events graded according to the active version of CTCAE [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Compared between arms using Fishers' exact test.
  • Quality of life, assessed using the FACT-C, neuro-toxicity questions, additional toxicity questions, and pain questions [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Local control [ Designated as safety issue: No ]
  • Frequence and severity of adverse events as assessed by NCI CTCAE active version [ Designated as safety issue: Yes ]
  • Treatment compliance [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Smoking history: prevalence of active smoking and extent of nicotine dependence [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

This randomized phase III trial is studying giving radiation therapy together with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

PRIMARY OBJECTIVES:

I. To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of patients treated with these regimens.

II. To assess differences in incidence and severity of regimen-attributed adverse events in these patients.

III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.

V. To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

TERTIARY OBJECTIVES:

I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients treated with these regimens.

II. To bank DNA from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo pelvic EBRT or IMRT 5 days a week for 5.5 weeks.

ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in arm I. Treatment with cisplatin repeats every 7 days for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy (FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at baseline and periodically during study.

Tumor tissue and blood samples may be collected and banked for future biomarker and other analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Stage IA Cervical Cancer
  • Stage IB Cervical Cancer
  • Stage IIA Cervical Cancer
  • Radiation: external beam radiation therapy
    Undergo radiotherapy
    Other Name: EBRT
  • Radiation: intensity-modulated radiation therapy
    Undergo radiotherapy
    Other Name: IMRT
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Active Comparator: Arm I (EBRT, IMRT)
    Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5½ weeks.
    Interventions:
    • Radiation: external beam radiation therapy
    • Radiation: intensity-modulated radiation therapy
  • Experimental: Arm II (cisplatin, EBRT, IMRT)
    Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in arm I. Treatment with cisplatin repeats every 7 days for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Radiation: external beam radiation therapy
    • Radiation: intensity-modulated radiation therapy
    • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
Not Provided
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed primary cervical cancer comprising one of the following cell types:

    • Squamous cell carcinoma
    • Adenosquamous carcinoma
    • Adenocarcinoma
  • Stage I-IIA disease
  • Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
  • Patients with depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed must meet the following criteria:

    • Positive capillary-lymphovascular space involvement and one of the following:

      • Deep third penetration
      • Middle third penetration, clinical tumor ≥ 2 cm
      • Superficial third penetration, clinical tumor ≥ 5 cm
    • Negative capillary-lymphatic space involvement

      • Middle or deep third penetration, clinical tumor ≥ 4 cm
  • No patients with tumor in the parametria, pelvic lymph nodes, or any other extra-uterine site or with positive surgical margins
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphate ≤ 3 times ULN
  • SGOT ≤ 3 times ULN
  • No septicemia or severe infection
  • No intestinal obstruction or gastrointestinal bleeding
  • No post-operative fistula
  • No circumstances that do not permit completion of the study or the required study follow-up
  • No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney or renal transplant)
  • No prior malignancy within the past 5 years except nonmelanoma skin cancer
  • No concurrent brachytherapy boost
  • At least 3 weeks but ≤ 8 weeks since surgery
  • No prior radiotherapy or chemotherapy for cancer of the cervix
  • No prior cancer treatment that contraindicates this protocol therapy
Female
18 Years and older
No
United States,   Japan,   Korea, Republic of
 
NCT01101451
GOG-0263, NCI-2011-02037, GOG-0263, CDR0000670125, GOG-0263, GOG-0263, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Sang Ryu Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

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