Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT01649089 |
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Recruitment Status :
Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : October 25, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Lymphedema Stage IA1 Cervical Cancer AJCC v6 and v7 Stage IA2 Cervical Cancer AJCC v6 and v7 Stage IB1 Cervical Cancer AJCC v6 and v7 | Procedure: Conization Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Therapeutic Conventional Surgery Procedure: Therapeutic Lymphadenectomy | Not Applicable |
PRIMARY OBJECTIVES:
I. To examine the changes before and after non-radical surgical treatment (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) on functional outcomes of bladder, bowel, and sexual function for stage IA1 (lymphatic vessel invasion positive [LVSI+]) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
II. To evaluate incidence and severity of lymphedema after non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To investigate if non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] with pelvic lymphadenectomy) demonstrates greater physical function and less toxicity in comparison to historical data on radical surgery (radical hysterectomy or radical trachelectomy).
II. To evaluate incidence and severity of treatment-related adverse events, including surgical complications, among the entire cohort and by treatment type.
III. To evaluate changes in quality of life (QOL) (Functional Assessment of Cancer Therapy-Cervix [FACT-Cx]), cancer worries (Impact of Events Scale [IES]) and sexual (Female Sexual Function Index [FSFI])/reproductive concerns (RCS) among the entire cohort and by treatment type.
IV. To explore relationships (correlation, interaction, independence) between functional outcomes (i.e., bladder function, bowel function, sexual function), adverse events (including and surgical complication lymphedema [Gynecologic Cancer Lymphedema Questionnaire (GCLQ)]), cancer worry (IES), surgical complications, and overall quality of life (FACT-Cx).
V. To determine participants' intention for conception & fertility rates (Integrative Care for Fertility [ICF]) and assess the reproductive concerns (RCS) of women following cone biopsy and pelvic lymphadenectomy for stage IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
VI. To estimate the efficacy of non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
OUTLINE:
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Patients complete the FACT-Cx, the IES, the FSFI, the GCLQ, and the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaires at baseline, 4-6 weeks after surgery, and then every 6 months for 3 years. Patients undergoing cone biopsy and pelvic lymphadenectomy also complete the ICF and RCS questionnaires.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 224 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer |
| Actual Study Start Date : | October 1, 2012 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
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Procedure: Conization
Undergo cone biopsy
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Therapeutic Conventional Surgery Undergo hysterectomy Procedure: Therapeutic Lymphadenectomy Undergo lymphadenectomy |
- Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question) [ Time Frame: Baseline to 3 years ]Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
- Change in sexual function and activity based on Female Sexual Function Index (19 items) score plus 2 Patient Reported Outcomes Measurement Information System screener items [ Time Frame: Baseline to 3 years ]Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
- Lymphedema [ Time Frame: Up to 3 years ]Based on Cancer Lymphedema Questionnaire score.
- Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema [ Time Frame: Up to 3 years after non-radical surgical procedure ]Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
- Maximum grade of treatment-related adverse events [ Time Frame: Up to 30 days after surgical procedure ]Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
- Change in overall quality of life [ Time Frame: Baseline to 3 years ]Will be assessed based on Functional Assessment of Cancer Therapy-Cervix (15 items) score. Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
- Change in cancer worries based on Impact of Events score [ Time Frame: Baseline to 3 years ]Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
- Change in reproductive concerns based on reproductive concerns (14 items) score [ Time Frame: Baseline to 3 years ]Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
- Site of first recurrence [ Time Frame: Up to 3 years ]Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).
- Recurrence-free survival [ Time Frame: Up to 3 years ]Product-limit estimates according to the method of Kaplan and Meier will be used to estimate recurrence-free survival. In addition, Cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Local recurrence will be summarized using frequency tables and plot of cumulative incidence of local recurrence over time.
- Overall survival [ Time Frame: Up to 3 years ]Product-limit estimates according to the method of Kaplan and Meier will be used to estimate overall survival. In addition, cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Gompertz hazard regression will also be employed to evaluate relative risk (hazard ratio) and cure rates, adjusting for known prognostics factors.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must consent for the appropriate surgery
- Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade
- All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm
- Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
Exclusion Criteria:
- Patients with stage IA1 disease who are LVSI negative
- Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm
- Patients with >= stage IB2 disease
- Patients with clear cell or neuroendocrine cell types
- Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649089
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| Principal Investigator: | Allan L Covens | NRG Oncology |
| Responsible Party: | GOG Foundation |
| ClinicalTrials.gov Identifier: | NCT01649089 |
| Other Study ID Numbers: |
GOG-0278 NCI-2012-01990 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000737208 GOG-0278 ( Other Identifier: NRG Oncology ) GOG-0278 ( Other Identifier: DCP ) GOG-0278 ( Other Identifier: CTEP ) U10CA101165 ( U.S. NIH Grant/Contract ) U10CA180868 ( U.S. NIH Grant/Contract ) UG1CA189867 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 25, 2012 Key Record Dates |
| Last Update Posted: | October 25, 2022 |
| Last Verified: | October 2022 |
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Carcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Lymphedema Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Lymphatic Diseases Neoplasms, Complex and Mixed |