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

Primary Purpose

Cervical Cancer

Status

Active

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

EFI

Pelvic RT

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Extended-field Irradiation (EFI), Cervical cancer, Hypoxia, Carbonic anhydrase 9 (CA9), locally advanced uterine cervical cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EFI(Extended-Field Irradiation)

Pelvic RT

Arm Description

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Pelvic Irradiation with chemotherapy(cisplatin)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00980759

First Posted

September 18, 2009

Last Updated

August 31, 2021

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00980759

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 28, 2006 (undefined)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomization of Radiotherapy field

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EFI(Extended-Field Irradiation)

Arm Type

Experimental

Arm Description

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Arm Title

Pelvic RT

Arm Type

Experimental

Arm Description

Pelvic Irradiation with chemotherapy(cisplatin)

Intervention Type

Radiation

Intervention Name(s)

EFI

Other Intervention Name(s)

Extended-field Irradiation

Intervention Description

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Intervention Type

Radiation

Intervention Name(s)

Pelvic RT

Other Intervention Name(s)

Pelvic only treatment

Intervention Description

Only Pelvic Irradiation with chemotherapy(cisplatin)

Primary Outcome Measure Information:

Title

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo-young J Kim, M.D., Ph.D.

Organizational Affiliation

National Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

undecided

Learn more about this trial

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

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