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

Purpose

RATIONALE: 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.

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.

Condition	Intervention	Phase
Cervical Cancer	Drug: cisplatin Radiation: external beam radiation therapy Radiation: intensity-modulated radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	480
Study Start Date:	April 2010
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5½ weeks.	Radiation: external beam radiation therapy Undergo radiotherapy Radiation: intensity-modulated radiation therapy Undergo radiotherapy
Experimental: 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.	Drug: cisplatin Given IV Radiation: external beam radiation therapy Undergo radiotherapy Radiation: intensity-modulated radiation therapy Undergo radiotherapy

Detailed Description:

OBJECTIVES:

Primary

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

To compare the overall survival (OS) of patients treated with these regimens.
To assess differences in incidence and severity of regimen-attributed adverse events in these patients.
To provide assessment of patient risk vs benefit (positive study only).
To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.
To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

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.
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

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
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
No concurrent brachytherapy boost

Contacts and Locations

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

Show 146 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Sang Y. Ryu, MD	Korea Cancer Center Hospital
Investigator:	Wui-jin Koh, MD	Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT01101451 History of Changes
Other Study ID Numbers:	CDR0000670125, GOG-0263
Study First Received:	April 9, 2010
Last Updated:	February 9, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer

cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases

Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013