Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

NCT ID: NCT02681432

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2019-12-31

Brief Summary

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Detailed Description

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization:

• HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
• No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPEC

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: DRUG

Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

No HIPEC

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Group Type: ACTIVE_COMPARATOR

No HIPEC

Intervention Type: PROCEDURE

Cytoreductive surgery without HIPEC

Interventions

HIPEC

Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

Intervention Type: DRUG

No HIPEC

Cytoreductive surgery without HIPEC

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
• Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
• No extra-abdominal tumor disease
• Absence of heart failure. Adequate renal and hepatic functions
• Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%

Exclusion Criteria

• Patients with unresectable tumor or incomplete cytoreduction.
• Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
• Extra-abdominal metastases or unresectable liver metastases
• Presence of other malignant tumor disease.
• Multisegmental complete bowel obstruction.
• Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
• Patients who refuse treatment or consent to participate in study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de Ciudad Real

OTHER

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: collaborator

PEDRO VILLAREJO CAMPOS

OTHER

Sponsor Role: lead

Responsible Party

PEDRO VILLAREJO CAMPOS

MD, PhD.Associate Professor of Surgery. University of Castilla-La Mancha

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pedro Villarejo Campos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SESCAM

Locations

Hospital General Ciudad Real

Ciudad Real, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pedro Villarejo Campos, MD,PhD

Role: CONTACT

villarejocampos@yahoo.es

926278000 ext. 79784

Facility Contacts

Javier Redondo-Calvo, MD PhD

Role: primary

References

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Reference Type: BACKGROUND

PMID: 19917539 (View on PubMed)

Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 12;2016(1):CD005340. doi: 10.1002/14651858.CD005340.pub4.

Reference Type: BACKGROUND

PMID: 26755441 (View on PubMed)

Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.

Reference Type: BACKGROUND

PMID: 16394300 (View on PubMed)

Chua TC, Robertson G, Liauw W, Farrell R, Yan TD, Morris DL. Intraoperative hyperthermic intraperitoneal chemotherapy after cytoreductive surgery in ovarian cancer peritoneal carcinomatosis: systematic review of current results. J Cancer Res Clin Oncol. 2009 Dec;135(12):1637-45. doi: 10.1007/s00432-009-0667-4. Epub 2009 Aug 23.

Reference Type: BACKGROUND

PMID: 19701772 (View on PubMed)

Bijelic L, Jonson A, Sugarbaker PH. Systematic review of cytoreductive surgery and heated intraoperative intraperitoneal chemotherapy for treatment of peritoneal carcinomatosis in primary and recurrent ovarian cancer. Ann Oncol. 2007 Dec;18(12):1943-50. doi: 10.1093/annonc/mdm137. Epub 2007 May 11.

Reference Type: BACKGROUND

PMID: 17496308 (View on PubMed)

Kim JH, Lee JM, Ryu KS, Lee YS, Park YG, Hur SY, Lee KH, Lee SH, Kim SJ. Consolidation hyperthermic intraperitoneal chemotherapy using paclitaxel in patients with epithelial ovarian cancer. J Surg Oncol. 2010 Feb 1;101(2):149-55. doi: 10.1002/jso.21448.

Reference Type: BACKGROUND

PMID: 20035540 (View on PubMed)

Benedetti Panici P, Palaia I, Graziano M, Bellati F, Manci N, Angioli R. Intraperitoneal paclitaxel as consolidation treatment in ovarian cancer patients: a case control study. Oncology. 2010;78(1):20-5. doi: 10.1159/000287968. Epub 2010 Feb 24.

Reference Type: BACKGROUND

PMID: 20185937 (View on PubMed)

de Bree E, Rosing H, Filis D, Romanos J, Melisssourgaki M, Daskalakis M, Pilatou M, Sanidas E, Taflampas P, Kalbakis K, Beijnen JH, Tsiftsis DD. Cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy with paclitaxel: a clinical and pharmacokinetic study. Ann Surg Oncol. 2008 Apr;15(4):1183-92. doi: 10.1245/s10434-007-9792-y. Epub 2008 Feb 1.

Reference Type: BACKGROUND

PMID: 18239973 (View on PubMed)

Seretis C, Youssef H. Quality of life after cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: a systematic review. Eur J Surg Oncol. 2014 Dec;40(12):1605-13. doi: 10.1016/j.ejso.2014.08.477. Epub 2014 Sep 6.

Reference Type: BACKGROUND

PMID: 25242382 (View on PubMed)

Other Identifiers

HGCRCIRU001

Identifier Type: -

Identifier Source: org_study_id