Know Cancer

or
forgot password

A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer


Inclusion Criteria:



- Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamous
carcinoma of the cervix (except FIGO IIIA)

- Deemed suitable and fit for radical chemoradiation

- Medically fit to receive carboplatin and paclitaxel

- ECOG performance status 0 - 1

- No evidence of active TB

- Aged 18 and over

- Adequate renal function, defined as a GFR ≥ 60 ml/min calculated using the Wright
equation (or ≥ 50 ml/min for radioisotope GFR assessment

- Adequate liver function, as defined by ALT or AST < 2.5 ULN and bilirubin < 1.25 ULN

- Adequate bone marrow function as defined by ANC ≥1.5 x 109/L, platelets ≥ 100 x 109/L

- Using adequate contraception precautions if relevant

- A documented negative HIV test (patients recruited from high risk countries or who
have moved within the past 10 years from high risk countries)

- Capable of providing written or witnessed informed consent

Patients with positive nodes (either histologically/PET positive ≥15 mm on CT/MRI) at or
below the level of the aortic bifurcation may be included in the study provided none of
the exclusion criteria apply.

Exclusion Criteria:

- Previous pelvic malignancy (regardless of interval since diagnosis)

- Previous malignancy not affecting the pelvis (except basal cell carcinoma of the
skin) where disease free interval is less than 10 years

- Positive lymph nodes (imaging or histological) above the aortic bifurcation*

- Involvement of lower 1/3 vagina (FIGO IIIA disease)

- Hydronephrosis which has not undergone ureteric stenting or nephrostomy except where
the affected kidney is non-functioning

- Evidence of distant metastasis i.e. any non-nodal metastasis beyond the pelvis

- Previous pelvic radiotherapy

- Prior diagnosis of Crohn's disease or Ulcerative colitis

- Documented positive HIV antibody test or HIV viral load (patients recruited from high
risk countries or who have moved within the past 10 years from high risk countries)

- Active TB

- Uncontrolled cardiac disease (defined as cardiac function which would preclude
hydration during cisplatin administration and any contraindication to paclitaxel)

- Pregnant or lactating * i.e. PET any size, CT/MRI ≥ 15mm

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Safety Issue:

No

Principal Investigator

Mary Dr McCormack, BSc, MSc, PhD, MBBS, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

UCL 11/0034

NCT ID:

NCT01566240

Start Date:

Completion Date:

June 2021

Related Keywords:

  • Cervical Cancer
  • Cervical cancer
  • Chemotherapy
  • Paclitaxel
  • Carboplatin
  • Cisplatin
  • Radiotherapy
  • Chemoradiation
  • Brachytherapy
  • Stage IB2 Cervical Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage IIIB Cervical Cancer
  • Stage IVA Cervical Cancer
  • Uterine Cervical Neoplasms

Name

Location