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Completed

NCT Number: NCT01905163

Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients

This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Cavity Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut de Cancerologie de l'Ouest, site Paul Papin, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > or = 18 years
  • performance status WHO < 2
  • Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed)
  • Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition.
  • No previous debulking surgery before neoadjuvant chemotherapy.
  • Patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy.
  • Response to chemotherapy was radiologically confirmed (Scan-TAP) prior to interval surgery:

No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy

  • able to read, write and understand French.
  • Member of a Social Security scheme.
  • written informed consent.

Exclusion criteria

  • Patient unable to support laparoscopy
  • psychiatric condition or social or geographic situation that would impede appropriate study participation
  • Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)

Treatment and study plan

Tumor Debulking Surgery by laparoscopy

Procedure

Primary outcomes

  1. the rate of conversion to laparotomy

    Time frame: surgery

    Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.

Secondary outcomes

  1. Port site metastases

    Time frame: during 1 year post surgery

  2. Morbidity: intraoperative and postoperative complications

    Time frame: during surgery and 1 year post surgery

  3. Pain

    Time frame: during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery

  4. Quality of life using EORTC QLQ-C30

    Time frame: before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery

  5. Economic evaluation

    Time frame: 1 year post-surgery

    economic evaluation will be assess by a quantification of the additional costs of surgery, duration and cost of hospitalization, number of possible re-interventions or hospitalizations.

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.

Acronym: CILOVE

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 23, 2013
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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