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Clinical Trials/EUCTR2008-003396-52-GB
EUCTR2008-003396-52-GB
Active, not recruiting
Phase 1

Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer.

European Organisation for Research and Treatment of Cancer0 sites686 target enrollmentSeptember 1, 2009
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ConditionsCervical carcinoma (including squamous cell carcinoma, adenosquamous cell or adenocarcinomaMedDRA version: 16.0Level: LLTClassification code 10008242Term: Cervical carcinoma stage IBSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10008244Term: Cervical carcinoma stage IIASystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10008245Term: Cervical carcinoma stage IIBSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsCisplatin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cervical carcinoma (including squamous cell carcinoma, adenosquamous cell or adenocarcinoma
Sponsor
European Organisation for Research and Treatment of Cancer
Enrollment
686
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2009
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
European Organisation for Research and Treatment of Cancer

Eligibility Criteria

Inclusion Criteria

  • •\- Cervical carcinoma of following histological types: squamous cell carcinoma, adenosquamous cell or adenocarcinoma
  • •\- FIGO stage Ib2, IIa \>4cm or IIb
  • •\- WHO performance status of 0\-2
  • •\- 18 \- 75 years
  • •\- No prior irradiation or chemotherapy
  • •\- No previous or concurrent second malignanct except for adequately treated basal cell carcinoma of the skin
  • •\- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule (those conditions should be discussed with the patient)
  • •\- not pregnant
  • •\- ANC \> 1\.5 x 109/l, platelets \> 100 x 109/l, bilirubin \< 25 µmol/l or \< 1\.46 mg/dl, creatinine clearance (calculated or measured) \> 60 ml/min
  • •\- Before patient randomization, written informed consent must be given according to ICH/GCP and national/local regulations.

Exclusion Criteria

  • •\- Small cell, clear cell and other rare variants of the classical adenocarcinoma
  • •\- prior irradiation or chemotherapy
  • •\- previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin
  • •\- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule (those conditions should be discussed with the patient before registration in the trial)
  • •\- pregnant

Outcomes

Primary Outcomes

Not specified

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