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A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Joo-Young Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01730651
First received: October 15, 2012
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  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 With Metastatic Lymphadenopathies at Initial Diagnosis
 Radiation: Intensity-modulated radiation therapy
 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:

U.S. FDA Resources

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 Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensity-modulated radiotherapy (IMRT)

1. 3 dimensional conformal radiotherapy of whole pelvis ± Para-aortic lymphatics, inguinal lymphatics

  1. T2a under: 45 Gy/25 fx
  2. T2b over: 50.4 Gy/28 fx * Fraction size = 1.8 Gy or 2 Gy

2. IMRT boost of gross LNs

  1. Tomotherapy fraction size (Gy) = 0.4 x diagnosis of 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 diagnosis of LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)
 Radiation: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730651

Locations
Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
National Cancer Center
Goyang-si,, Gyeonggi-do, Korea, Republic of, 411-769
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: November 15, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013