Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

NCT02681432 | Unknown Phase 3

• 1 other identifier: HGCRCIRU001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epithelial Ovarian Cancer

Keywords

HIPEC; ovarian cancer; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)

  every 6 months till 36 months

Secondary Outcomes (1)

• Progression free survival

  follow up every 6 months till 18 months

Other Outcomes (1)

• Post-operative complications

  adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE))

Study Arms (2)

HIPEC

EXPERIMENTAL

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

Drug: HIPEC

No HIPEC

ACTIVE COMPARATOR

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

Procedure: No HIPEC

Interventions

HIPEC DRUG

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

HIPEC

No HIPEC PROCEDURE

Cytoreductive surgery without HIPEC

No HIPEC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• PEDRO VILLAREJO CAMPOS: lead
• Hospital General de Ciudad Real: collaborator
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Hospital General Ciudad Real

Ciudad Real, 13005, Spain

RECRUITING

Related Publications (9)

• Munoz-Casares FC, Rufian S, Rubio MJ, Diaz CJ, Diaz R, Casado A, Arjona A, Munoz-Villanueva MC, Muntane J. The role of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in the treatment of peritoneal carcinomatosis in recurrent ovarian cancer. Clin Transl Oncol. 2009 Nov;11(11):753-9. doi: 10.1007/s12094-009-0438-3.

  PMID: 19917539 BACKGROUND

• 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.

  PMID: 26755441 BACKGROUND

• 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.

  PMID: 16394300 BACKGROUND

• 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.

  PMID: 19701772 BACKGROUND

• 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.

  PMID: 17496308 BACKGROUND

• 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.

  PMID: 20035540 BACKGROUND

• 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.

  PMID: 20185937 BACKGROUND

• 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.

  PMID: 18239973 BACKGROUND

• 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.

  PMID: 25242382 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Pedro Villarejo Campos, MD, PhD

  SESCAM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Villarejo Campos, MD,PhD

CONTACT

926278000; villarejocampos@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD.Associate Professor of Surgery. University of Castilla-La Mancha

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 12, 2016
• Study Start: January 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)