Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer

NCT01561586 | Unknown Phase 3 DMC

• 1 other identifier: KGOG 1027/THAI 2012
• Study Type: interventional
• Target: 374
• Locations: 4 countries
• Sites: 15

Brief Summary

Current standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiation (CRT). 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. In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better outcome in locally advanced cervical cancer. In this randomized phase III trial, the investigators investigate that there may be a survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 administration concurrent to RT in cervical cancer.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Concurrent chemoradiation; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.

  From entry into the study to 5 year after treatment or death

Secondary Outcomes (4)

• Progression Free Survival

  5 year after treatment

• Recurrence rate

  5 year after therapy

• Adverse events

  5 years after therapy

• Compliance to radiation protocol

  56~ 67 days after treatment start

Study Arms (2)

A: Weekly cisplatin with RT

ACTIVE COMPARATOR

Weekly cisplatin 40mg/m2 six cycles concurrent to radiation therapy

Drug: Weekly cisplatin with RT

B: Tri-weekly cisplatin with RT

EXPERIMENTAL

Tri-weekly cisplatin 75mg/m2 three cycles concurrent to radiation therapy

Drug: Tri-weekly cisplatin with RT

Interventions

Weekly cisplatin with RT DRUG

Cisplatin 40mg/m2 IV Weekly For 6 Cycles.(The 6th cycle of cisplatin may be omitted if external beam radiation therapy has been completed) Cisplatin may be diluted and administered per established institutional guidelines. For general suggestion, 40 mg/ m2 of cisplatin may be diluted in 250 ml 0.9% sodium chloride and administered over one or two hours. Cisplatin will be given on the first day of external RT (Day 1), preferably, and must be given prior to radiation treatment on that day External beam RT will be followed by intracavitary brachytherapy. The total elapsed time for completion of external beam to the whole pelvis, intracavitary BT, and parametrial / nodal RT shall not exceed eight weeks (56 days)

Also known as: Cisplatin

A: Weekly cisplatin with RT

Tri-weekly cisplatin with RT DRUG

Tri-weekly cisplatin 75mg/m2 three cycles concurrent to radiation therapy Cisplatin may be diluted and administered per established institutional guidelines. For general suggestion, 75 mg/m2 of cisplatin may be diluted in 500 ml 0.9% sodium chloride and administered over one or two hours (rate of 1 mg of cisplatin per minute). Cisplatin will be given on the first day of external RT (Day 1), preferably, and must be given prior to radiation treatment on that day. External beam RT will be followed by intracavitary brachytherapy. The total elapsed time for completion of external beam to the whole pelvis, intracavitary BT, and parametrial / nodal RT shall not exceed eight weeks (56 days)

Also known as: Cisplatin

B: Tri-weekly cisplatin with RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intent
• FIGO 2008 stage 1B2, 2B, 3B, 4A
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have adequate Hematologic function(ANC ≥ 1,500/mcl and platelets ≥ 100,000/mcl), Renal function(serum creatinine ≤ ULN or calculated creatinine clearance ≥ 60 mL/min), Hepatic function(serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN)
• Patients must have signed an approved informed consent

You may not qualify if:

• Patients with cervix cancer who have received any previous radiation or chemotherapy
• Patients assessed at presentation as requiring interstitial brachytherapy treatment
• FIGO stage 3A disease
• Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive or \> 15mm short axis diameter on CT)
• Previous chemotherapy for this tumor
• Evidence of distant metastases
• Prior diagnosis of Crohn's disease or ulcerative colitis
• Patients who are pregnant or lactating
• History of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
• Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Gangnam Severance Hospital: collaborator

Study Sites (15)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Dongnam Inst.of Radiological/Medical Science

Busan, South Korea

RECRUITING

Soon Chun Hyang University Hospital

Cheonan, South Korea

RECRUITING

Dongsan Medical Center

Daegu, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

Gachon University Gil Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Kyungpook National University Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital/Sinchon Severance Hospital

Seoul, South Korea

RECRUITING

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

RECRUITING

Ho Chi Minh City Oncology Hospital

Ho Chi Minh City, Vietnam

RECRUITING

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• SANG YOUNG SY RYU, M.D.

  STAFF

  PRINCIPAL INVESTIGATOR

• SARIKAPAN WILAILAK, M.D.

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANG YOUNG RYU, M.D.

CONTACT

82-2-970-1227; ryu@kcch.re.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Cerivcal/Ovarian Cancer Center

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 23, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2023
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

TH (1); CN (1); KR (12); VN (1)