Endometrial AdenocarcinomaPhase 3NCT00002706
Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
A Phase 3 study testing Laparoscopic Surgery, Quality-of-Life Assessment and Therapeutic Conventional Surgery in people with Endometrial Adenocarcinoma and Stage I Uterine Corpus Cancer, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Stage I Uterine Corpus Cancer, Stage I Uterine Sarcoma
- What is being tested?
- Laparoscopic Surgery, Quality-of-Life Assessment and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,616 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
- Must be considered a candidate for surgery
- No contraindication to laparoscopy
- No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
- Performance status - GOG 0-3
- WBC at least 3,000/mm^3
Show all 15Show fewer
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Creatinine no greater than 2.0 mg/dL
- Prior malignancy allowed if no current evidence of disease
- Not pregnant
- No prior pelvic or abdominal radiotherapy
- See Disease Characteristics
- No prior retroperitoneal surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III
This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.
Read the detailed description
OBJECTIVES:
- Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.
II. Compare the length of hospital stay after surgery in patients receiving these treatments.
III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy.
ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
- Conditions
- Endometrial Adenocarcinoma, Stage I Uterine Corpus Cancer, Stage I Uterine Sarcoma, Stage II Uterine Corpus Cancer, Stage II Uterine Sarcoma
- Being tested
- Laparoscopic Surgery, Quality-of-Life Assessment, Therapeutic Conventional Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SurgeryProcedure or surgery
Also called laparoscopic-assisted resection, laparoscopy-assisted surgery
Undergo vaginal hysterectomy and BSO via laparoscopy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo total abdominal hysterectomy and BSO via conventional laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo vaginal hysterectomy and BSO via laparoscopy. Receives: Procedure: Laparoscopic Surgery; Other: Quality-of-Life Assessment |
| Arm II | Active comparator | Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy. Receives: Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of disease-free interval
The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.
Measured: Up to 5 years
Frequency of aborting LAVH in order to perform an TAH/BSO
Measured: Up to 5 years
Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse
Measured: Up to 5 years
Length of hospitalization following surgery
A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
Measured: From the date of surgery to the date of discharge, assessed up to 5 years
Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1996
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joan Walker, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002706
- Sponsor's protocol ID
- GOG-LAP2
- Other IDs
- NCI-2012-02237, CDR0000064513, GOG-LAP2, GOG-LAP2, U10CA027469
- Status last verified
- May 2015
- First submitted
- 1 Nov 1999
- Last updated
- 29 May 2015
- Results posted
- No
Publications
Bishop EA, Java JJ, Moore KN, Spirtos NM, Pearl ML, Zivanovic O, Kushner DM, Backes F, Hamilton CA, Geller MA, Hurteau J, Mathews C, Wenham RM, Ramirez PT, Zweizig S, Walker JL. Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study. Am J Obstet Gynecol. 2018 Jan;218(1):109.e1-109.e11. doi: 10.1016/j.ajog.2017.09.026. Epub 2017 Oct 14.
PubMed 29037481
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III
- ClinicalTrials.gov ID
- NCT00002706
- Acronym / sponsor ID
- GOG-LAP2
- Conditions
- Endometrial Adenocarcinoma, Stage I Uterine Corpus Cancer, Stage I Uterine Sarcoma, Stage II Uterine Corpus Cancer, Stage II Uterine Sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,616 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1996
- Primary completion
- Mar 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.
Detailed description
OBJECTIVES:
- Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.
II. Compare the length of hospital stay after surgery in patients receiving these treatments.
III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy.
ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: Laparoscopic Surgery, Other: Quality-of-Life AssessmentPatients undergo vaginal hysterectomy and BSO via laparoscopy. |
| Arm II | Active comparator | Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional SurgeryPatients undergo total abdominal hysterectomy and BSO via conventional laparotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
- Must be considered a candidate for surgery
- No contraindication to laparoscopy
- No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
- Performance status - GOG 0-3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic SurgeryAlso: laparoscopic-assisted resection, laparoscopy-assisted surgeryUndergo vaginal hysterectomy and BSO via laparoscopy | Procedure or surgery | Arm I |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I, Arm II |
| Therapeutic Conventional SurgeryUndergo total abdominal hysterectomy and BSO via conventional laparotomy | Procedure or surgery | Arm II |
Primary outcome
Duration of disease-free interval
Time frame: Up to 5 years
The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.
Frequency of aborting LAVH in order to perform an TAH/BSO
Time frame: Up to 5 years
Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse
Time frame: Up to 5 years
Length of hospitalization following surgery
Time frame: From the date of surgery to the date of discharge, assessed up to 5 years
A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Derived from this study: PubMed 29037481Bishop EA, Java JJ, Moore KN, Spirtos NM, Pearl ML, Zivanovic O, Kushner DM, Backes F, Hamilton CA, Geller MA, Hurteau J, Mathews C, Wenham RM, Ramirez PT, Zweizig S, Walker JL. Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study. Am J Obstet Gynecol. 2018 Jan;218(1):109.e1-109.e11. doi: 10.1016/j.ajog.2017.09.026. Epub 2017 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Walker principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic Surgery, Quality-of-Life Assessment and Therapeutic Conventional Surgery in people with Endometrial Adenocarcinoma and Stage I Uterine Corpus Cancer, run by Gynecologic Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of disease-free interval (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.