Ovarian CarcinomaPhase 3NCT00715286
Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
A Phase 3 study testing timing of surgery in people with Ovarian Carcinoma, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- timing of surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2001to Jun 2009
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:20 to 65 years
- Epithelial ovarian carcinoma
- Stage IIIc \& IV (pleural effusion only)
- ECOG PS 0-2
- Cytology/biopsy positive patients
- Good compliance
- Previously untreated patients
Who cannot join
- Any medical contraindication of surgery
- Psychiatric illness
- Cardiac, liver or renal dysfunction
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Lalit Kumar, DM, lalitaiims@yahoo.com
Lalit Kumar, DM
About this study
Official title: Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study
To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.
- Conditions
- Ovarian Carcinoma
- Being tested
- timing of surgery
- Keywords
- epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timing of surgeryOther
Surgery is followed by chemotherapy
timing of surgeryOther
Chemotherapy is followed by surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Conventional arm: primary surgery followed by chemotherapy Receives: Other: timing of surgery |
| B | Experimental | Neoadjuvant chemotherapy followed by interval debulking Receives: Other: timing of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Measured: post surgery
Secondary outcomes (1)
post operative morbidity
Measured: 3 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startNov 2001
- Primary completionApr 2007 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Lalit Kumar, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715286
- Sponsor's protocol ID
- I473
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00715286
- Acronym / sponsor ID
- I473
- Conditions
- Ovarian Carcinoma
- Keywords
- epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Apr 2007 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 15 Jul 2008 (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.
To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: timing of surgeryConventional arm: primary surgery followed by chemotherapy |
| B | Experimental | Other: timing of surgeryNeoadjuvant chemotherapy followed by interval debulking |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age:20 to 65 years
- Epithelial ovarian carcinoma
- Stage IIIc \& IV (pleural effusion only)
- ECOG PS 0-2
- Cytology/biopsy positive patients
Key exclusion criteria (3 listed)
- Any medical contraindication of surgery
- Psychiatric illness
- Cardiac, liver or renal dysfunction
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 |
|---|---|---|
| timing of surgerySurgery is followed by chemotherapy | Other | A |
| timing of surgeryChemotherapy is followed by surgery | Other | B |
Primary outcome
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Time frame: post surgery
1 secondary outcome
post operative morbidity
Time frame: 3 weeks post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2008.
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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.
Lalit Kumar, DM principal investigator
All India Institute of Medical Sciences
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 timing of surgery in people with Ovarian Carcinoma, run by All India Institute of Medical Sciences at 1 site in India.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2008. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lalit Kumar, DM (91-11-26593405, lalitaiims@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group (time frame: post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2008.