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Brief Title: Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma

Four Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial - FOCUS Study -

INTRODUCTION

  • Org Study ID: KCSG GU16-02
  • Secondary ID: N/A
  • NTC ID: NCT03296306
  • Sponsor: Asan Medical Center

BRIEF SUMMARY


The objective is to show non-inferiority of overall survival between four cycles and six
cycles of first-line cisplatin based chemotherapy to determine the optimal duration of
chemotherapy in patients with advanced urothelial carcinoma.

DETAILED DESCRIPTION


Urothelial carcinoma is the fifth most common cancer in men and seventh among women all
around the world. Although a complete surgical resection with or without perioperative
treatment is the most effective way to offer a potentially curative therapy to patients with
these cancers, 25% of the patients initially present with locally or systemically advanced
disease. Systemic chemotherapy is the only current modality that provides the potential for a
long-term survival in patients with advanced or metastatic urothelial disease.

Cisplatin based combination chemotherapies such as GP, GP-S, MVAC, and dose dense MVAC with
G-CSF supports are regarded as a backbone treatment for patients with advanced bladder cancer
on the basis of the results from previous studies.

However, there is no consensus on appropriate number of chemotherapy cycles. In phase III
trial comparing MVAC with GP, patients were treated with 6 cycles (every 4 weeks) of
chemotherapy. In another phase III trial comparing MVAC with HD-MVAC, there is no
pre-determined number of cycles, but the median number of cycles were 4 for MVAC and 6 for
HD-MVAC.

However, it is hard to complete six or more cycles of cisplatin based chemotherapy due to
cumulative toxicities of cisplatin such as neuropathy and development of resistance. The
median age of patients with urothelial cancer is 70 years old and significant proportion of
the patients already showed impaired performance status (ECOG PS ≥2).

There has already been reported in several trials of NSCLC, which showed that 4 cycles of
chemotherapy containing cisplatin has no significant differences in survival or QoL with
lower incidences of toxicities compared with 6 cycles of chemotherapy.

The objective of this trial is to assess whether there is any difference in OS between
patients who are treated with four cycles of cisplatin based chemotherapy and patients who
are treated with 6 cycles of chemotherapy to determine the optimal duration of chemotherapy
in patients with advanced urothelial cancer.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival

Primary Outcome 1 - Timeframe: 5 years

CONDITION

  • Bladder Cancer
  • Ureter Cancer
  • Urethral Cancer
  • Transitional Cell Carcinoma

ELIGIBILITY


Inclusion criteria:

1. Patients with histologically or cytologically confirmed urothelial cancer

2. Unresectable locally advanced (T3b, N2-3), metastatic (M1), or recurrent disease

3. Age 18 years or older

4. Eastern Cooperative Oncology Group performance status 0-1

5. Not progressed disease status after 2 or 4 cycles of platinum-based chemotherapy

6. Adequate organ and bone marrow function for chemotherapy

7. No history of radiation therapy, or radiation field within 25% of whole marrow would
be allowed. If patients underwent radiation therapy in entire pelvis, they are
excluded to this study. Patients should discontinue radiation therapy at least 4 weeks
before enrollment, and the patients should be recovered from radiation therapy
associated adverse events.

8. Women should use contraceptive medication for 6 months after the end of the study or
she would be post-menopause status. Men should consent with the contraception for 6
months after the end of the study or he would be infertile.

9. Patients should sign a written informed consent before study entry.

Exclusion Criteria:

1. Histologic types other than urothelial cell carcinoma should be excluded. However,
urothelial cell types combined with squamous or glandular features are allowed.

2. Patients who showed progressed disease status after 2 or 4 cycles of platinum-based
chemotherapy, cannot be treated with additional chemotherapy due to adverse events, or
already undertook with reduced dose of more than 50%

3. Presence or history of CNS metastasis

4. Prior systemic chemotherapy (But prior intravesical chemotherapy or immunotherapy was
allowed, and recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic
chemotherapy is allowed if the last chemotherapy was administered 1 year or more
before the patient enrollment)

5. Peripheral sensory neuropathy grade 2 or worse according to NCI CTCAE

6. History of treatment with drugs of another clinical trial within 30 days before
enrollment.

7. Concomitant severe medical, surgical, or psychiatric disease or problems which can
affect the results of the clinical trial or have possibilities of unexpected medical
problems caused be the drug of clinical trial

8. History of another malignancy (but treated malignancy at least two years before
enrollment were allowed, and cured non-melanoma skin cancer, any cured in-situ
carcinoma, clinically insignificant localized prostate cancer, or papillary thyroid
carcinoma are allowed even diagnosed less than 2 years before enrollment).

9. Pregnant or lactating women, women of childbearing potential not employing adequate
contraception

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jae-Lyun Lee, MD., PhD.

Role: Principal Investigator

Affiliation: Asan Medical Center

Overall Contact

Name: Jae-Lyun Lee, MD., PhD.

Phone: +82-2-3010-5977

Email: jaelyun@amc.seoul.kr

LOCATION

Facility Status Contact
Facility: Kwonoh Park
Yangsan, Gyeongsangnam-do 50612
Korea, Republic of
Status: Recruiting Contact:
Kwonoh Park, MD, PhD
1033783529
parkkoh@daum.net
Facility: Hallym University Medical Center, Hallym University College of Medicine
Anyang,
Korea, Republic of
Status: Recruiting Contact:
Ho Young Kim

ksfam@daum.net
Facility: Fatima Hospital
Daegu,
Korea, Republic of
Status: Recruiting Contact:
Jung Lim Lee

junglim3@gmail.com
Facility: Keimyeong University Dongsan Medical Center
Daegu,
Korea, Republic of
Status: Recruiting Contact:
Jin Young Kim, MD

takgu@dsmc.or.kr
Facility: Chungnam University Hospital
Daejeon,
Korea, Republic of
Status: Recruiting Contact:
Hyo Jin Lee, MD, PhD.

cymed@cnu.ac.kr
Facility: National Health Insurance Service Ilsan Hospital
Goyang,
Korea, Republic of
Status: Recruiting Contact:
Soo Jung Hong

suzzy901@nhimc.or.kr
Facility: Gil Medical Center
Incheon,
Korea, Republic of
Status: Recruiting Contact:
Inkeun Park, MD, PhD

ingni79@hanmail.net
Facility: Inje University Haeundae Paik Hospital
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Il-Hwan Kim

onelement@daum.net
Facility: Kosin University Hospital
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Sung-Hoon Shin

ssh1533@daum.net
Facility: Pusan National University Hospital, Pusan National University School of Medicine
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Hyo Jung Kim

leonkim80@naver.com
Facility: Asan Medical Center
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Jae-Lyun Lee, MD, PhD

jaelyun@amc.seoul.kr
Facility: Chung Ang University Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Hee Joon Kim

Facility: Inje University Sanggye Paik Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Byeong Seok Sohn

imbs@paik.ac.kr
Facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Yun-Gyoo Lee

gosciny@gmail.com
Facility: Korea University Anam Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Yoon Ji Choi

yoonji23@hanmail.net
Facility: Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Bhum Suk Keam

Facility: VHS medical center
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Bong-Seog Kim

Facility: Yonsei Cancer Center
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Sang Joon Shin

ssj338@yuhs.ac
Facility: St. Vincent's Hospital, The Catholic University of Korea
Suwon,
Korea, Republic of
Status: Recruiting Contact:
Byoung Yong Shim

shimby@catholic.ac.kr