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

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0006118
• Lead Sponsor: Korea Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-23
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

1. Patient must consent for the appropriate surgery (see Section 4.0).
2. Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix, Stage IA1 (LVSI+), IA2, and IB1 (tumor size [maximum visible or palpable]) = 2cm), any grade.
3. All patients must have undergone a cone biopsy or LEEP procedure. Depth of invasion must be = 10 mm.
4. Patients must have no evidence of metastasis on PET Scan or MRI or CT scan of the pelvis and chest imaging. (09/14/2015)
5. Patients who have met the pre-entry requirements specified in Section 7.0.
6. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
7. Patients must be > 18 years of age.
8. Patient must have GOG performance status of 0, 1, or 2.

Exclusion Criteria

1. Patients with Stage IA1 disease who are LVSI negative.
2. Patients with Stage IB1 with tumor size (maximum visible or palpable) > 2 cm.
3. Patients with = Stage IB2 disease.
4. Patients with clear cell or neuroendocrine cell types.
5. Patients with depth of invasion >10mm on first cone biopsy (or LEEP).
6. 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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. 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;2. 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;3. Lymphedema;4. Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema

Secondary Outcome Measures

Name	Time	Method
1. Maximum grade of treatment-related adverse events;2. Change in overall quality of life based on Functional Assessment of Cancer Therapy-Cervix (15 items) score;3. Change in cancer worries based on Impact of Events score;4. Change in reproductive concerns based on reproductive concerns (14 items) score;5. Site of first recurrence;6. Recurrence-free survival;7. Overall survival