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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Joo-Young Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01730651
First received: October 15, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Cervical Cancer
Radiation: IMRT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis.

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Overall survival [ Time Frame: documented data of death, up to 3 years ] [ Designated as safety issue: No ]
    From date of initiation of radiotherapy until the date of documented date of death from any cause, assessed up to 3 years


Secondary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: documented date of progression or death, up to 3 years ] [ Designated as safety issue: No ]

    From date of initiation of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

    • Progression-free survival of lymph nodes(LNs) treated with high dose ② Regional LN (other than the LNs treated with high dose) failure-free survival ③ Distant organ (other than para-aortic LNs[PAN]) failure-free survival


Other Outcome Measures:
  • Toxicity [ Time Frame: every follow-up date, up to 3 years ] [ Designated as safety issue: No ]

    ① Acute: gastrointestinal (GI), genitourinary (GU), bone marrow (BM)

    ② Late: GI, GU, lower extremity edema, treatment-related neuropathy, bone density change



Estimated Enrollment: 55
Study Start Date: July 2012
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Intensity-modulated radiotherapy (IMRT)

1. 3D-CRT of whole pelvis ± Para-aortic lymphatics, inguinal lymphatics

  1. T2a 이하: 45 Gy/25 fx
  2. T2b 이상: 50.4 Gy/28 fx (단, medial parametrium만 involve한 T2b의 경우에는 45 Gy/25 fx도 허용) * Fraction size는 1.8 Gy 또는 2 Gy 모두 허용

2. 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)
Radiation: IMRT
Intensity modulated radiation therapy

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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…)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730651

Contacts
Contact: Jooyoung Kim, M.D. +82-31-920-1724 jooyoungcasa@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Joo-Young Kim, M.D., Ph.D.    +82 31 920 1724    jooyoungcasa@ncc.re.kr   
Principal Investigator: Jooyoung Kim, M.D         
Sub-Investigator: Seokgi Kim, M.D.         
Sub-Investigator: Taesung Kim, M.D.         
Sub-Investigator: Sunho Kim, M.D.         
Sub-Investigator: Yoenju Kim, M.D.         
Sub-Investigator: Duhyeon Lee, R.T.T         
National Cancer Center Recruiting
Goyang-si,, Gyeonggi-do, Korea, Republic of, 411-769
Contact: Jooyoung Kim, M.D.    +82-31-920-1724    jooyoungcasa@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jooyoung Kim, M.D. National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Joo-Young Kim, PI, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01730651     History of Changes
Other Study ID Numbers: NCCCTS 12-615
Study First Received: October 15, 2012
Last Updated: September 29, 2014
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
cervical cancer with metastatic lymphadenopathies

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014