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
  Purpose

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.


Condition Intervention Phase
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
Radiation: intensity-modulated radiation therapy
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 480
Study Start Date: April 2010
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5½ weeks.
Radiation: external beam radiation therapy
Undergo radiotherapy
Other Name: EBRT
Radiation: intensity-modulated radiation therapy
Undergo radiotherapy
Other Name: IMRT
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101451

  Show 280 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Sang Ryu Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01101451     History of Changes
Other Study ID Numbers: GOG-0263, NCI-2011-02037, GOG-0263, CDR0000670125, GOG-0263, GOG-0263, U10CA027469
Study First Received: April 9, 2010
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014