Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer

NCT00980759 | Unknown

• 1 other identifier: NCCCTS-06-209
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia marker) expression in the primary cervical tumor before randomization because it was expected that there would be a differential benefit of EFI in patients with CA9-positive vs CA9-negative tumors. However, the study design was modified because there was too much delay in the patient with CA9-negative tumors. The patients are now registered and then immediately randomized to experimental (EFI) and control arm (pelvis only treated) with examination of CA9 expression at later time.

Conditions

Cervical Cancer

Keywords

Extended-field Irradiation (EFI); Cervical cancer; Hypoxia; Carbonic anhydrase 9 (CA9); locally advanced uterine cervical cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer

  5 years

Secondary Outcomes (1)

• To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients

  5 years

Study Arms (2)

EFI(Extended-Field Irradiation)

EXPERIMENTAL

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Radiation: EFI

Pelvic RT

EXPERIMENTAL

Pelvic Irradiation with chemotherapy(cisplatin)

Radiation: Pelvic RT

Interventions

EFI RADIATION

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Also known as: Extended-field Irradiation

EFI(Extended-Field Irradiation)

Pelvic RT RADIATION

Only Pelvic Irradiation with chemotherapy(cisplatin)

Also known as: Pelvic only treatment

Pelvic RT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB with only unilateral pelvic wall extension, and IVA
• Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
• Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
• Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
• Patients who have signed an approved informed consent and authorization
• Patients who have met the pre-entry requirements specified in section 6.0.
• Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
• Age: 18≤age≤80

You may not qualify if:

• Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
• Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
• Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non- malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joo-young J Kim, M.D., Ph.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization of Radiotherapy field

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: July 28, 2006
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2024
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

KR (1)