Trial Concept Weekly VS Three Weekly Chemotherapy for Chemoradiation in Cervical Cancer Dr Sarikapan Wilailak* * Endorsed by the TGCS (Thai Gynecologic Cancer Society) - PowerPoint PPT Presentation

Title: Trial Concept Weekly VS Three Weekly Chemotherapy for Chemoradiation in Cervical Cancer Dr Sarikapan Wilailak* * Endorsed by the TGCS (Thai Gynecologic Cancer Society)


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Trial Concept Weekly VS Three Weekly
Chemotherapy for Chemoradiation in Cervical
CancerDr Sarikapan Wilailak Endorsed by the
TGCS (Thai Gynecologic Cancer Society)
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Cervical cancer in 2002 (n500,000)(Developed
and developing countries)
DEVELOPED COUNTRIES DEVELOPED COUNTRIES DEVELOPED COUNTRIES DEVELOPING COUNTRIES DEVELOPING COUNTRIES DEVELOPING COUNTRIES
SITE Attrib to HPV () TOTAL cancers Attrib to HPV all cancer TOTAL cancers Attrib to HPV all cancer
CERVIX 100 83,400 83,400 1.7 409,400 409,400 7.0
CERVIX 100 83,400 83,400 1.7 409,400 409,400 7.0
CERVIX 100 83,400 83,400 1.7 409,400 409,400 7.0
Ferlay J et al. Globocan 2002. IARC 2004.
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Cancer in Thailand, Vol.IV, 1998-2000 2007
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New cases / year 6,243
Deaths / year 2,620
In Thailand, each day 7 women die from cervical
cancer
Ferlay J et al. Globocan 2002. IARC 2004
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Concurrent chemoradiation
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In 1999, the USNCI issued a statement that
concurrent chemoradiation should be considered
for all patients with advanced cervical cancer
(based on 5 RCT and recently Keys et al, Marris
et al., Rose et al., Whitney et al., Peters et
al.)
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Meta analysis of Concurrent Chemo RT vs RT (18
RCT)
Chemoradiotherapy for cervical cancer
meta-analysis collaboration. J Clin Oncol
2008265802-12
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(No Transcript)
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Nowadays, concurrent chemoradiation has become
the gold standard treatment for locally advanced
cervical cancer.
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Weekly cisplatin

• VS

Three weekly cisplatin
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Weekly VS three weekly

• Three weekly chemotherapy could save a
  considerable amount of resources
• There has been no randomized study that compares
  the two types of chemotherapeutic administration
  mentioned.

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Weekly VS three weekly

• The question of interest in this proposal is
  whether weekly or three weekly chemotherapy for
  chemoradiation in locally-advanced cervical
  cancer is comparable in terms of efficacy,
  toxicities, and cost effectiveness.

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Objectives

• Primary objectives will be to determine
• Progression-free survival
• Acute toxicities
• Cost effectiveness of the treatments
• Secondary objectives will be to determine
• Overall survival
• long-term toxicities
• Patterns of disease recurrence
• Acceptability of patients
• Patients quality of life

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Inclusion criteria

• Stage IB2 to IVA
• Squamous and adenocarcinoma
• ECOG performance status 0-2
• WBC 3.0 x 109/L and ANC 1.5 x 109/L
• Platelets 100 x 109/L
• Bilirubin 1.5 x UNL
• AST/ALT 2.5 x UNL
• Adequate renal function creatinine 1.5 ? or
  calculated creatinine clearance (CockCroft-Gault
  Formula) 60ml/min
• No contraindication to the use of cisplatin
• Informed consent

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Exclusion criteria

• High-risk histologies (adenosquamous, clear cell
  etc)
• Neoadjuvant chemotherapy
• Previous pelvic radiotherapy
• Patients with other invasive malignancies, with
  the exception of non-melanoma skin cancer, who
  had (or have) any evidence of the other cancer
  present within the last 5 years
• Pregnancy
• Serious illness or medical condition that
  precludes the safe administration of the trial
  treatment
• HIV positive

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Study Design and procedure

• multi-centre randomized phase III trial.
• Arm A Weekly chemoradiation
• Arm B Three weekly chemoradiation
• Standard radiation treatment will be given in
  both arms
• The overall treatment time should not exceed
  eight weeks.

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• In arm A, cisplatin will be given during the
  radiation at a dose of 40mg/m2 weekly for 6
  doses, within 4 weeks of completion of all
  radiation treatment.
• In arm B, cisplatin will be given during the
  radiation at a dose of 70mg/m2 three weekly for 3
  doses, within 4 weeks of completion of all
  radiation treatment.

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Outcomes

• Primary outcomes
• Progression-free survival rates
• Acute toxicity rate
• Cost effectiveness ratio of the treatments
• Secondary outcomes
• Overall survival rates
• long-term toxicity rate
• Patterns of disease recurrence
• Acceptability rate of patients
• Patients quality of life score