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Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT00916500
First received: June 7, 2009
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.

However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.

Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.

Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.

We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).

Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.


Condition Intervention Phase
CERVICAL NEOPLASMS
 Drug: CONCURRENT CHEMORADIATION (CISPLATIN)
 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 Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:
  • DISEASE-FREE SURVIVAL [ Time Frame: 5 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DISEASE-FREE SURVIVAL [ Time Frame: 2 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]
  • OVERALL SURVIVAL [ Time Frame: FROM THERAPY TO DEATH ] [ Designated as safety issue: No ]
  • RECURRENCE RATE [ Time Frame: 2 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]
  • RECURRENCE RATE [ Time Frame: 5 YEAR AFTER THERAPY ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: March 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CISPLATIN
Patients With Locally Advanced Cervical Cancer Who Underwent Concurrent Chemoradiation; Cisplatin 75mg/m2 IV Every 3 Week For 3 Cycles; External Pelvic Radiation 40 Gy; Brachytherapy Up to 85-90 Gy To Point A
 Drug: CONCURRENT CHEMORADIATION (CISPLATIN)
Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
Other Name: Cisplatin

Detailed Description:

Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in early-stage disease. However, advanced disease carries a poor prognosis.

Current standard treatment for locally advanced cervical cancer, which is not eligible for surgical treatment, is cisplatin-based concurrent chemoradiation. On the basis of the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based chemoradiation, the U.S. National Cancer Institute (NCI) announced in 1992 that "Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with radiotherapy in women who require radiotherapy for treatment of cervical cancer".

Although recently reported meta-analyses also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent with radiation, the optimal cisplatin dose and dosing schedule are still undetermined.

Among the previous five randomized clinical trials, two trials performed by the Gynecologic Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil (5-FU). Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU combined regimens.

However weekly cisplatin regimen needs frequent hospital visits and had a poor compliance profile in korea. With weekly cisplatin regimen, planned treatment was not completed in 58% patients adn treatment delayed in 29% patient. among these patients, 9% patients were not related associated toxicities.

To overcome toxicities and poor compliance of weekly regimen, the investigators tried to evaluate the efficacy and feasibility of CCRT with cisplatin 75mg/m2 every 3 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically confirmed cervical cancer
  2. Clinical stage from 2b to 4a
  3. Equal to or younger than 75
  4. Gog performance status 0 - 2
  5. Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl
  6. Serum creatinine < 2.0
  7. AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl
  8. Expected survival equal to or longer than 6 months
  9. Who agreed to participate in this study

Exclusion criteria:

  1. History of chemotherapy or radiation to abdomen or pelvis
  2. History of other cancers
  3. Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2
  4. History of allergy or hypersensitivity reaction to platinum
  5. History of atrial or ventricular arrhythmia, or congestive heart failure
  6. Uncontrolled diabetes, hypertension, or ischemic heart disease
  7. Myocardial infarction within 6 months
  8. Sepsis or severe infection
  9. Pregnant women
  10. An unapproved therapy within 30 days before enrollment
  11. Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916500

Locations
Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, Korea, Republic of, 139-706
Sponsors and Collaborators
Korea Cancer Center Hospital
Investigators
Principal Investigator: SANG YOUNG RYU, M.D. STAFF
  More Information

No publications provided

Responsible Party: Sang-Young Ryu, Chair of Cerivcal/Ovarian Cancer Center, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00916500     History of Changes
Other Study ID Numbers: KCCH GY 1001
Study First Received: June 7, 2009
Last Updated: March 27, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea Cancer Center Hospital:
CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013