Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01365156
First received: June 1, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
The goal of this clinical research study is to learn if a surgical procedure called an extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can help to control the disease for a longer time than standard-of-care chemotherapy and whole pelvic radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Squamous Cell Carcinoma Adenosquamous Carcinoma Adenocarcinoma Locally Advanced Malignant Neoplasm Cervical Cancer |
Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND) Radiation: Chemoradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Three Year Overall Survival Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall survival (OS) with the product limit estimator of Kaplan and Meier
overall survivals with pretherapeutic para-aortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy after PET scan only.
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | September 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EPLND + Chemoraditation
Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy
|
Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND)
Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment
Other Names:
Radiation: Chemoradiation
Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks.
|
|
Active Comparator: Chemoradiation
Group 2: standard-of-care chemoradiation therapy only
|
Radiation: Chemoradiation
Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
- Women with planned treatment of primary definitive chemoradiation therapy.
- An approved Informed Consent and authorization permitting release of personal health information must be signed by the patient or guardian.
Exclusion Criteria:
- Women with stage IA or IB1 cancer.
- Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
- Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
- Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
- Women who have undergone simple or radical hysterectomy prior to radiotherapy.
- Women with planned treatment of radiotherapy only (without chemotherapy).
- Women with planned treatment of palliative radiotherapy.
- Women with metastatic disease outside of pelvis.
- Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer.
- Women who are pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365156
Contacts
| Contact: Michael M. Frumovitz, MD, MPH | 713-792-9599 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Michael M. Frumovitz, MD, MPH | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Michael M. Frumovitz, MD, MPH | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01365156 History of Changes |
| Other Study ID Numbers: | 2010-0952 |
| Study First Received: | June 1, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
locally advanced cervical cancer pretherapeutic para-aortic surgical staging radiologic staging pretherapeutic surgical staging para-aortic metastatic disease |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Carcinoma Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous |
Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed |
ClinicalTrials.gov processed this record on June 17, 2013