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Surgery or Chemotherapy in Secondary Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03983226
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group

Brief Summary:
The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) in platinum-sensitive secondary recurrent ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Fallopian Tube Cancer Primary Peritoneal Carcinoma Procedure: Secondary cytoreductive surgery Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... Phase 2

Detailed Description:
This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy, versus chemotherapy alone in patients with platinum-sensitive secondary recurrent ovarian cancer who never received secondary cytoreduction when recurrent.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Secondary Cytoreduction in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Secondary cytoreductive surgery

Intervention:

Procedure: Maximum effort cytoreductive surgery Drug: Platinum-based chemotherapy

Procedure: Secondary cytoreductive surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
Other Name: secondary cytoreduction

Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Other Name: third-line chemotherapy

Active Comparator: Salvage chemotherapy
Intervention: Drug: Platinum-based chemotherapy
Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Other Name: third-line chemotherapy




Primary Outcome Measures :
  1. 6-month disease non-progression rate [ Time Frame: 6 months ]
    6-month non-progression rate


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to 24 months after last patient randomized ]
    from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)

  2. Treatment free intervals [ Time Frame: Up to 24 months after last patient randomized ]
    the intervals of the ending date from system anticancer therapy to the starting date of the subsequent anticancer therapy or death

  3. Overall Survival [ Time Frame: Approximately up to 24 months after last patient randomized ]
    from date of randomization until the date of death from any cause

  4. 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    surgical complications grading criteria will be adopted for evaluating the perioperative complications

  5. Quality of life assessment [ Time Frame: baseline; 6 and 12 months after randomization ]
    the European Organization for Research and Treatment (EORTC) core quality of life questionnaire (QLQ-C30, version 3.0) The total score (range from 0 to 1,000)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years to ≤ 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer, which is defined as those with platinum-free interval of 6 months or more.
  • Front-line or second-line treatment may have included maintenance therapy
  • Never received secondary cytoreductive surgery when recurrence
  • Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis.
  • It can be included if single lesion outside the peritoneal cavity can be resected.
  • 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.
  • Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded.
  • Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
  • Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
  • Third 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 second-line platinum-based 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983226


Contacts
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Contact: Rong Jiang, M.D. +862164041990 jiang.rong@zs-hospital.sh.cn
Contact: Yuting Luan, R.N. +862164041990 yutingluan@163.com

Locations
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China, Shanghai
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Investigators
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Principal Investigator: Tingyan Shi, M.D., Ph.D. Shanghai Gynecologic Oncology Group
Study Chair: Rongyu Zang, M.D., Ph.D. Shanghai Gynecologic Oncology Group

Additional Information:
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Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT03983226     History of Changes
Other Study ID Numbers: SGOG OV5
SGOG OV-05 ( Other Identifier: Shanghai Gynecologic Oncology Group )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Gynecologic Oncology Group:
reurrent Ovarian Cancer
Secondary Cytoreductive Surgery
Chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasm Metastasis
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplastic Processes
Pathologic Processes
Fallopian Tube Diseases
Gemcitabine
Carboplatin
Doxorubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors