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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980759
Recruitment Status : Active, not recruiting
First Posted : September 21, 2009
Last Update Posted : September 8, 2021
Information provided by (Responsible Party):
Joo-Young Kim, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: EFI Radiation: Pelvic RT Not Applicable

Detailed Description:
Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix are included in this study. Absence of metastatic para-aortic lymphadenopathy is the prerequisite of the enrollment, and this is confirmed by imaging studies such as MRI covering the abdomen and pelvis, and PET/CT scan. The sample size is based on the previous studies (1-3). Considering that the disease-free survival of the experimental arm (patients who are treated with prophylactic para-aortic LN irradiation) and those who are not treated is 82% vs 72% (preliminary analysis), with the alpha error of 5% and statistical power of 90% (one-sided), a total of 140 patients in each treatment arm is needed. With 10% of follow-up loss taken into account, the total number of patients will be 312. Above figures were calculated on the basis of 80% statistical power and 5% type I error rate. PAN is treated prophylactically in the experimental arm with 45Gy/25F/5week fractionation schedule. Pelvis is treated according to the individual institute's practice guideline. Boost treatment for any enlarged pelvic lymph node or residual cervical/ parametrial disease with conformal radiation technique are allowed. Intracavitary radiation is given via low-dose-rate or high-dose-rate brachytherapy technique. Weekly cisplatin is given to all patients, however, when the patient's physical condition does not allow cisplatin administration, it can be omitted. This should be taken into account in the final analysis. The stage and the presence of pelvic lymphadenopathy are two stratification factors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization of Radiotherapy field
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Prophylactic Irradiation of the Para-Aortic Lymph Nodes by 3-D Conformal Radiotherapy Technique With Concurrent Chemotherapy Based on the Hypoxic Status of Locally Advanced Uterine Cervical Cancer
Study Start Date : July 28, 2006
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: EFI(Extended-Field Irradiation)
Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)
Radiation: EFI
Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)
Other Name: Extended-field Irradiation

Experimental: Pelvic RT
Pelvic Irradiation with chemotherapy(cisplatin)
Radiation: Pelvic RT
Only Pelvic Irradiation with chemotherapy(cisplatin)
Other Name: Pelvic only treatment

Primary Outcome Measures :
  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 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
  3. 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.
  4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
  5. Patients who have signed an approved informed consent and authorization
  6. Patients who have met the pre-entry requirements specified in section 6.0.
  7. Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
  8. Age: 18≤age≤80

Exclusion Criteria:

  1. Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
  2. Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
  3. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00980759

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Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
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Principal Investigator: Joo-young J Kim, M.D., Ph.D. National Cancer Center
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Responsible Party: Joo-Young Kim, Principal Investigator, National Cancer Center, Korea Identifier: NCT00980759    
Other Study ID Numbers: NCCCTS-06-209
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo-Young Kim, National Cancer Center, Korea:
Extended-field Irradiation (EFI)
Cervical cancer
Carbonic anhydrase 9 (CA9)
locally advanced uterine cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical 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