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

NCT01730651 | Unknown DMC

• 1 other identifier: NCCCTS 12-615
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cervical Cancer

Keywords

cervical cancer with metastatic lymphadenopathies

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of initiation of radiotherapy until the date of documented date of death from any cause, assessed up to 3 years

  documented data of death, up to 3 years

Secondary Outcomes (1)

• Disease-free survival (DFS)

  documented date of progression or death, up to 3 years

Other Outcomes (1)

• RTOG acute and late Toxicity

  every follow-up date, up to 3 years

Study Arms (1)

Tomotherapy

EXPERIMENTAL

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: Tomotherapy

Interventions

Tomotherapy 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)

Tomotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[ING\])
• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2
• 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.
• Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.
• Patients who have signed an approved informed consent and authorization

You may not qualify if:

• Patients with recurrent LN(s) which was(were) previously irradiated.
• Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
• Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g. supraclavicular or mediastinal metastatic lymphadenopathy)
• Patients with distant organ metastasis (e.g. bone, lung, brain…)

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (2)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jooyoung Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: November 21, 2012
• Study Start: July 13, 2012
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

KR (2)