Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
This study is currently recruiting participants.
Verified January 2013 by Shanghai Gynecologic Oncology Group
Sponsor:
Shanghai Gynecologic Oncology Group
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
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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
- Accompanied by hypoxia serious chronic obstructive pulmonary disease
- Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
- Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
- Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
- Uncontrolled diabetes
- 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
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:
|
Carcinoma Ovarian Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 22, 2013