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Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients

Phase 2
Open (Enrolling)
Cervical Neoplasms

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Trial Information

Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients

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

The standard postoperative treatment for patients with cervical cancer who had high-risk
factors is chemoradiation. Based on the results of five randomized clinical trials, which
consistently showed improved survival in patients treated with cisplatin-based CRT, the
National Cancer Institute (NCI) of the United States announced that 'Strong consideration
should be given to the incorporation of concurrent cisplatin-based chemotherapy with RT in
women who require radiation therapy for treatment of cervical cancer' in 1999.

Although recently reported meta-analysis studies also demonstrated improved local control
rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT),
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, as a result of the GOG 165 study, which was closed prematurely because an interim
analysis found that patients in the 5-FU treatment group were not likely to achieve a better
outcome, the role of 5-FU (previously popularly included in clinical trials) as a
radiosensitizer became subject to debate. Furthermore, a clinical trial performed by the NCI
in Canada comparing pelvic RT alone with weekly cisplatin 40 mg/m2 concurrent to RT failed
to show improvement of progression free and 5-year survival. While the authors suggested
several possible reasons for why their study failed to demonstrate a survival benefit with
concurrent weekly cisplatin 40 mg/m2 chemotherapy, other investigators have tried to find
another optimal dose and dosing schedule for cisplatin administration.

In light of the results of the previous clinical trial that indicated 5-FU may not be an
active radiosensitizer, weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 remain
the most popular cisplatin doses and dosing schedules. However, despite the possible
advantages of tri-weekly cisplatin 75 mg/m2, which offer an increased peak concentration of
cisplatin and cisplatin administration during brachytherapy, no clinical trials have
efficacy of tri-weekly cisplatin-based chemotherapy concurrent to RT.

Therefore, the investigators are going to perform the efficacy study of postoperative,
tri-weekly cisplatin chemoradiation for patients with cervical cancer.

Inclusion Criteria:

- cervical cancer

- underwent radical hysterectomy

- non-small cell type

- FIGO stage 1B - 2A

- have one or more risk factors (lymph node involvement, resection margin involvement,
parametrial involvement)

- GOG performance status 0 - 2

Exclusion Criteria:

- Previous history of chemotherapy or radiation

- History of other cancer

- Hypersensitivity to platinum agents

- Pregnancy

- Serious medical disease

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator

Sang-Young Ryu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea Institute of Radiological & Medical Sciences


Korea: Institutional Review Board

Study ID:

KCCH GY 1002



Start Date:

July 2009

Completion Date:

July 2016

Related Keywords:

  • Cervical Neoplasms
  • Cervical neoplasms
  • Cisplatin
  • Concurrent Chemoradiation
  • Neoplasms
  • Uterine Cervical Neoplasms