Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shanghai Gynecologic Oncology Group
Sponsor:
Collaborators:
Fudan University
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01611766
First received: May 30, 2012
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.


Condition Intervention Phase
Ovarian Epithelial Cancer Recurrent
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Procedure: Secondary Cytoreductive Surgery
Drug: Salvage Chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Shanghai Gynecologic Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: Up to 36 months after last patient randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Progression-free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first), assessed up to 36 months. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6, 12, and 24 months after randomization ] [ Designated as safety issue: Yes ]
  • complications incidence [ Time Frame: From the operation until after 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: January 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secondary cytoreductive surgery
SCR followed by chemotherapy
Procedure: Secondary Cytoreductive Surgery
Complete Cytoreduction
Other Name: Debulking Surgery
Drug: Salvage Chemotherapy
Active Comparator: Salvage Chemotherapy
platinum-based chemotherapy
Drug: Salvage Chemotherapy

Detailed Description:

The primary objective of this study is to compare overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer with a positive SCR score randomized to secondary cytoreductive surgery followed by chemotherapy versus chemotherapy alone.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at recurrence ≥ 18 years
  • Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
  • A complete secondary cytoreduction predicting score, iMODEL [Tian WJ, Ann Surg Oncol 2012,19(2):597-604]<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0).
  • Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.
  • Patients who have given their signed and written informed consent and their consent.

Exclusion Criteria:

  • Patients with borderline tumors as well as non-epithelial tumors.
  • Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
  • Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.
  • More than one prior chemotherapy.
  • Second relapse or more
  • Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
  • Progression during chemotherapy or recurrence within 6 months after first-line therapy
  • Any contradiction not allowing surgery and/or chemotherapy

    1. Accompanied by hypoxia serious chronic obstructive pulmonary disease
    2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
    3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
    4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
    5. Uncontrolled diabetes
    6. Uncontrolled epilepsy need long-term antiepileptic treatment.
  • Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611766

Contacts
Contact: Xiao Huang, MD, PhD +862164175590 smilehuangxiao@163.com
Contact: Yuting Luan, RN +862164175590 fudanGOG@gmail.com; yutingluan@163.com

Locations
China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xiao Huang, MD,PhD    +862164175590    smilehuangxiao@163.com   
Principal Investigator: Rongyu Zang, MD,PhD         
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01611766     History of Changes
Other Study ID Numbers: V02_2010_10
Study First Received: May 30, 2012
Last Updated: January 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Gynecologic Oncology Group:
secondary cytoreductive surgery
Ovarian Cancer
surgery
recurrence

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on October 19, 2014