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

Brief Title

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

Official Title

Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

Brief Summary

      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.

Detailed Description

      The primary objective is to determine whether secondary cytoreduction followed by
      chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS)
      and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

 Accumulating Treatment-free survival (TFSa)

Condition

Ovarian Epithelial Cancer Recurrent

Intervention

Secondary Cytoreductive Surgery

Study Arms / Comparison Groups

 secondary cytoreductive surgery

Description:  SCR followed by chemotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

July 19, 2012

Completion Date

December 2022

Primary Completion Date

December 2019

Eligibility 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). If PI and CO-PI reach
consensus that the recurrent tumor detected by PET/CT could be completely resected,
the index of CA125 could be scored as 0. (Revised on 09/30/2013)

- 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.

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Rongyu Zang, MD,PhD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01611766

Organization ID

SGOG OV 2

Secondary IDs

SGOG OV2

Responsible Party

Sponsor

Study Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

 Fudan University

Study Sponsor

Rongyu Zang, MD,PhD, Principal Investigator, Shanghai Gynecologic Oncology Group

Verification Date

June 2021