eo-ESCAPE (Neoadjuvant Extended Sequential Chemotherapy with Adjuvant Postoperative treatment for Epithelial non-mucinous advanced inoperable peritoneal malignancy): a randomised feasibility study of extended chemotherapy with neoadjuvant carboplatin, then surgery followed by adjuvant paclitaxel & gemcitabine versus neoadjuvant gemcitabine and carboplatin, then surgery followed by adjuvant paclitaxel. - Neo-ESCAPE

Phase 1

• Conditions: Epithelial non-mucinous advanced inoperable peritoneal malignancy (ovarian carcinoma, ovarian carcinosarcoma, fallopian tube or primary peritoneal carcinoma); MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer

• Registration Number: EUCTR2005-001875-37-GB
• Lead Sponsor: niversity of Warwick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

Principal
1)Clinical, radiological and histological findings consistent with a diagnosis of primary epithelial ovarian cancer, or primary peritoneal carcinoma, ovarian carcinosarcoma, or fallopian tube carcinoma.

2)Patients must be unsuitable for primary debulking surgery as defined by laparoscopic staging procedures, supplemented by clinical and radiological assessments.

3)Patients (or their legally acceptable representative) must be able to provide full written consent

4)ECOG Performance status 0, 1, 2, 3.

5)Estimated GFR > than or equal to 30ml/min using the Wright formula

6)AST/ALT/Alk. Phos. < 2.5 x upper limit of normal; Bilirubin < 1.5x normal

7)WBC >3.0; Platelets > 100 x 109/L.

8)Age > than or equal to 18 years

9)Life expectancy of at least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Principal exclusion criteria:
1)Patients deemed suitable for debulking surgery

2)Any of the following histology: mucinous; classic clear cell; micropapillary or microacinar borderline tumours with or without invasive implants

3)Diabetics, hypertensive smokers and other patients with pre-existing occult neuropathic deficits and women >75 years of age.

4)Poorly controlled potentially serious medical conditions such as cerebrovascular events within the previous 12 months;

5)Prior malignancy, chemotherapy or radiotherapy (except for those with non-melanoma skin cancer or cervix insitu). Previous malignancies disease free for more that 5 years not treated with chemotherapy will be allowed

6)Known brain metastases

7)Other reasons likely to cause inability to comply with treatment schedule and follow up

8)Those of child-bearing potential not employing adequate contraception which may include prescription contraceptives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified