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Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial

ConditionsAdvanced Ovarian CarcinomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid TumorFallopian Tube Serous NeoplasmFallopian Tube Transitional Cell CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaStage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma or pathology consistent with high-grade mullerian carcinoma.

Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity. Pleural effusions are acceptable per the local PI's discretion.

Normalization of CA-125 according to individual participating center reference range (Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot exceed 35 U/mL at the completion of NACT prior to interval debulking surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or laparotomy.

Disqualifiers

Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the following findings that may preclude minimally invasive resection per surgeon's assessment. • Failure of improvement of ascites during NACT (trace ascites is allowed) • Small bowel or gastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumor involvement • Splenic or hepatic surface or parenchymal tumor involvement • Mesenteric tumor involvement • Tumor infiltration of the lesser peritoneal sac

History of psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule

Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed by participating institution's clinicians

Any other contraindication to MIS as assessed by the clinician

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    Receive standard of care chemotherapy

  • Laparotomy

    Procedure/Surgery

    Undergo laparotomy

  • Minimally Invasive Surgery

    Procedure/Surgery

    Undergo MIS

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

580 Participants
are divided into 2 treatment groups
Group A: Arm A (MIS, standard of care chemotherapy)Experimental treatment 4 interventions
Group B: Arm B (laparotomy, standard of care chemotherapy)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Disease free survival (DFS)

Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).

Time frame
Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years

Secondary outcomes

1

Health related-quality of life (HR-QoL)

HR-QoL of patients will be assessed with European Organization for Research and Treatment of Cancer (EORTC Scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)

Time frame
Up to 1 year post surgery chemotherapy
2

Health related-quality of life (HR-QoL)

HR-QoL of patients will be assessed Quality of Life Questionnaire-Core 30 (QLQC30 scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)

Time frame
Up to 1 year post surgery chemotherapy
3

Health related-quality of life (HR-QoL)

HR-QoL of patients will be assessed with QLQ-Ovarian Cancer Module (OV28 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).) (ovarian supplement)

Time frame
Up to 1 year post surgery chemotherapy
4

Health related-quality of life (HR-QoL)

HR-QoL of patients will be assessed with Functional Assessment of Cancer Therapy-General short-form (FACT-G7 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).

Time frame
Up to 1 year post surgery chemotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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