Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
Condition: CERVICAL NEOPLASMS
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): CONCURRENT CHEMORADIATION (CISPLATIN)
Intervention type(s): Drug
Intervention description(s): Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
Other intervention name(s): Cisplatin
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN