High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies.

NCT ID: NCT01730651

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-13
• Study Completion Date: 2022-07-31

Brief Summary

This phase II study of high dose intensity modulated radiation therapy in the cervical cancer with metastatic lymphadenopathies at initial diagnosis

Detailed Description

Lymph node (LN) involvement in cervical cancer is a poor prognostic factor(1). Although lymph node evaluation is not a part of the International Federation of Gynecology and Obstetrics (FIGO) staging system(2), it is generally performed as one of the initial workup of patients with cervical cancer by use of modern imaging tools for accurate evaluation of the disease extent and possible treatment adjustment. Kidd et al reported the positron emission tomography with [18F] fluorodeoxyglucose (FDG-PET)-positive lymph node rate is 47% at diagnosis in 560 patients. They also showed that within a stage, patients with PET-positive lymph nodes had significantly worse disease specific survival than those with PET-negative lymph nodes (p<0.001)(3).

Historically, dose escalation to the pelvic or para-aortic metastatic lymphadenopathies was not given as much attention as primary uterine cervical lesion partly because of the expected increased risk of bowel toxicity with when conventional radiotherapy technique was used. Unlike for the head and neck cancer where intensity modulated radiation therapy (IMRT) or tomotherapy was actively used for treatment of large lymphadenopathies and shown to produce improved disease control(4, 5) , there are few similar studies for cervical cancer. It is well known that more than 60 Gy10 2Gy equivalent dose (EQD2, α/β=10 Gy) is needed to control the gross tumor sized of 10 mm, containing 109 cells, according to the logarithmic cell killing(6). Theoretically, pelvic and para-aortic LNs (PAN) could not be controlled with the dose of 45-50 Gy10 EQD2, and we need to escalate the dose as much as possible with new radiation technology.

In the current is study, we evaluate the LNs control rate, toxicity rate, progression-free survival and overall survival in cervical cancer patients with lymphadenopathies and treated with high dose intensity modulated radiation therapy

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tomotherapy

1. Tomotherapy fraction size (Gy) = 0.4 x 진단 당시의 LN short diameter (cm) + 1.6 (pilot study range, 1.5-3.0 Gy)

2. Total dose(summation dose with 3D-CRT) (Gy10) (EQD2, α/β=10 Gy) = 5 x 진단 당시의 LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)

Group Type: EXPERIMENTAL

Tomotherapy

Intervention Type: RADIATION

IMRT boost of gross LNs

1. Tomotherapy fraction size (Gy) = 0.4 x 진단 당시의 LN short diameter (cm) + 1.6 (pilot study range, 1.5-3.0 Gy)

2. Total dose(summation dose with 3D-CRT) (Gy10) (EQD2, α/β=10 Gy) = 5 x 진단 당시의 LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)

Interventions

Tomotherapy

IMRT boost of gross LNs

1. Tomotherapy fraction size (Gy) = 0.4 x 진단 당시의 LN short diameter (cm) + 1.6 (pilot study range, 1.5-3.0 Gy)

2. Total dose(summation dose with 3D-CRT) (Gy10) (EQD2, α/β=10 Gy) = 5 x 진단 당시의 LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed carcinoma of the uterine cervix (including clear cell and small cell carcinoma), with metastatic lymphadenopathies (any of pelvis or PAN >1.5 cm in short diameter, with/without biopsy proven inguinal lymph node [ING])

2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2

3. Patients with adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning.

4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.

5. Patients who have signed an approved informed consent and authorization

Exclusion Criteria

1. Patients with recurrent LN(s) which was(were) previously irradiated.

2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer

3. Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g. supraclavicular or mediastinal metastatic lymphadenopathy)

4. Patients with distant organ metastasis (e.g. bone, lung, brain…)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joo-Young Kim

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jooyoung Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS 12-615

Identifier Type: -

Identifier Source: org_study_id