## Protocol Section
### Identification Module
**NCT ID:** NCT01345279

**Brief Title:** Indirect Comparison Topotecan Cervical Carcinoma

**Official Title:** Indirect Comparison of the Efficacy Between Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix

#### Organization Study ID Info
**ID:** 114016
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2009-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-07

**Type:** ACTUAL

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2011-05-02
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-16
**Study First Submit QC Date:** 2011-04-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some differences between the respective study populations. Patients with prior chemotherapy were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in GOG-0169 (27%) than in GOG-0179 (\~60%) and these patients were unevenly distributed between treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated with the indirect meta-analysis.

### Conditions Module

**Conditions:**

- Cervical Intraepithelial Neoplasia

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: cisplatin

**Label:** cisplatin

#### Arm Group 2

**Intervention Names:**

- Drug: cisplatin

- Drug: topotecan

**Label:** cisplatin + topotecan

#### Arm Group 3

**Intervention Names:**

- Drug: cisplatin

- Drug: paclitaxel

**Label:** cisplatin + paclitaxel

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cisplatin

- cisplatin + paclitaxel

- cisplatin + topotecan

**Description:** 50 mg/m2 IV cisplatin on day 1 and then every 3 weeks for 6 courses

**Name:** cisplatin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- cisplatin + topotecan

**Description:** topotecan 0.75 mg/m2 on days 1, 2, and 3. The regimen was repeated every 3 weeks for 6 courses

**Name:** topotecan

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- cisplatin + paclitaxel

**Description:** 135 mg/m2 paclitaxel on day 1 and then every 3 weeks for 6 courses

**Name:** paclitaxel

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Overall survival

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* randomised clinical trials, or systematic reviews and meta-analyses
* treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

* None

**Minimum Age:** 21 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The search was designed to identify all clinical data published since the Cancer Care Ontario systematic review in 2006. The Cancer Care Ontario systematic review searched MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006), the Cochrane Library (Cochrane Database of Systematic Reviews (2006 Issue 1), and Cochrane Controlled Trials Register (2006 Issue 1)), the Canadian Medical Association Infobase, and the National Guidelines Clearinghouse. The conference proceedings of the American Society of Clinical Oncology (1995-2005) and the European Society of Medical Oncology (2002-2005) were also searched. The search was completed on 18 December 2008

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000011230

- Term: Precancerous Conditions

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M5826

- Name: Uterine Cervical Dysplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T1074

- Name: Cervical Intraepithelial Neoplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

### Condition Browse Module - Meshes

- ID: D000002578

- Term: Uterine Cervical Dysplasia

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000059004

- Term: Topoisomerase I Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M21674

- Name: Topotecan

- Relevance: HIGH

- As Found: PD-1

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29349

- Name: Topoisomerase I Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000019772

- Term: Topotecan

### Misc Info Module

- Version Holder: 2024-05-24
