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

NCT01611766 | Unknown Phase 3 DMC

• 2 other identifiers: SGOG OV 2SGOG OV2
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 4

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.

Conditions

Ovarian Epithelial Cancer Recurrent; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

Keywords

secondary cytoreductive surgery; Ovarian Cancer; surgery; recurrence

Outcome Measures

Primary Outcomes (2)

• Overall survival

  from date of randomisation until death

  Up to 60 months after last patient randomized

• Progression-free survival

  interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first

  Up to 24 months after last patient randomized

Secondary Outcomes (8)

• Accumulating Treatment-free survival (TFSa)

  Up to 60 months after last patient randomized

• Overall survival after the adjustment of one-way treatment switching

  Up to 60 months after last patient randomized

• 30-day post-operative complications

  From the operation until after 30 days

• Validation of iMODEL

  From randomization to operation

• Patient compliance

  Up to 60 months after last patient randomized

Study Arms (2)

secondary cytoreductive surgery

EXPERIMENTAL

SCR followed by chemotherapy

Procedure: Secondary Cytoreductive Surgery; Drug: Salvage Chemotherapy

Salvage Chemotherapy

ACTIVE COMPARATOR

platinum-based chemotherapy

Drug: Salvage Chemotherapy

Interventions

Secondary Cytoreductive Surgery PROCEDURE

Complete Cytoreduction

Also known as: Maximum effort cytoreductive surgery

secondary cytoreductive surgery

Salvage Chemotherapy DRUG

6 cycles of postoperative chemotherapy

Also known as: second line chemotherapy

Salvage Chemotherapy; secondary cytoreductive surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead
• Fudan University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Sun Yat-sen University: collaborator

Study Sites (4)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

• Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1.

  PMID: 38824243 DERIVED

• Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8.

  PMID: 33705695 DERIVED

Related Links

• Shanghai Gynecologic Oncology Group

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rongyu Zang, MD,PhD

  Shanghai Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 5, 2012
• Study Start: July 19, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

CN (4)